United States Prevention, Pesticides EPA 738-R-98-017
Environmental Protection And Toxic Substances December 1998
Agency (7508C)
&EPA Reregistration
Eligibility Decision (RED)
AL & MG Phosphide
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregi strati on eligibility review and decisions on the pesticide chemical cases aluminum and
magnesium phosphide [Case Numbers 0025 & 0645]. The enclosed Reregi strati on Eligibility
Decision (RED), which was approved on September 30, 1998, contains the Agency's evaluation
of the data base of this chemical, its conclusions of the potential human health and environmental
risks of the current product uses, and its decisions and conditions under which these uses and
products will be eligible for reregistration. Please note that an extensive stakeholder involvement
process will begin shortly to determine the best methods for reducing the risks associated with
these pesticides. Following this process, the Agency will identify specific risk mitigation measures
which will need to be implemented in order for these pesticides to be eligible for reregistration.
The RED includes the data and labeling requirements for products for reregistration. It also
includes requirements for additional data (generic) on the active ingredient to confirm the risk
assessments.
To assist you with a proper response, read the enclosed document entitled "Summary of
Instructions for Responding to the RED." This summary also refers to other enclosed documents
which include further instructions. You must follow all instructions and submit complete and
timely responses. The first set of required responses is due 90 days from the receipt of this
letter. Complete and timely responses will avoid the Agency taking the enforcement action of
suspension against your products.
Please note that the Food Quality Protection Act of 1996 (FQPA) became effective on
August 3, 1996, amending portions of both pesticide law (FIFRA) and the food and drug law
(FFDCA). This RED takes into account, to the extent currently possible, the new safety standard
set by FQPA for establishing and reassessing tolerances. However, it should be noted that in
continuing to make reregistration determinations during the early stages of FQPA implementation,
EPA recognizes that it will be necessary to make decisions relating to FQPA before the
implementation process is complete. In making these early case-by-case decisions, EPA does not
intend to set broad precedents for the application of FQPA. Rather, these early determinations
will be made on a case-by-case basis and will not bind EPA as it proceeds with further policy
development and any rulemaking that may be required.
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If EPA determines, as a result of this later implementation process, that any of the
determinations described in this RED are no longer appropriate, the Agency will pursue whatever
action may be appropriate, including but not limited to reconsideration of any portion of this
RED.
If you have questions on the product specific data requirements or wish to meet with the
Agency, please contact the Special Review and Reregi strati on Division representative Bonnie
Adler (703) 308-8523. Address any questions on required generic data to the Special Review and
Reregi strati on Division representative Mark Hartman (703) 308-0734.
Sincerely,
Lois A. Rossi, Director
Special Review and
Reregi strati on Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
reregi strati on, a DCI letter will be enclosed describing such data. If product specific data are
required, a DCI letter will be enclosed listing such requirements. If both generic and product
specific data are required, a combined Generic and Product Specific DCI letter will be enclosed
describing such data. However, if you are an end-use product registrant only and have been
granted a generic data exemption (GDE) by EPA, you are being sent only the product specific
response forms (2 forms) with the RED. Registrants responsible for generic data are being sent
response forms for both generic and product specific data requirements (4 forms). You must
submit the appropriate response forms (following the instructions provided) within 90 days
of the receipt of this RED/DCI letter; otherwise, your product may be suspended.
2 TIME EXTENSIONS AND DATA WAIVER REOUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data should
be submitted in the 90-day response. Requests for data waivers must be submitted as part of the
90-day response. All data waiver and time extension requests must be accompanied by a full
justification. All waivers and time extensions must be granted by EPA in order to go into effect.
3 APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the issuance of final
mitigation measures following the conclusion of the stakeholder process.
a. Application for Reregistration (EPA Form 8570-1) Use only an original application
form. Mark it "Application for Reregistration." Send your Application for Reregistration (along
with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregi strati on) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregistration. For further labeling
guidance, refer to the labeling section of the EPA publication "General Information on Applying
for Registration in the U.S., Second Edition, August 1992" (available from the National Technical
Information Service, publication #PB92-221811; telephone number 703-605-6000).
c. Generic or Product Specific Data. Submit all data in a format which complies with
PR Notice 86-5, and/or submit citations of data already submitted and give the EPA identifier
(MRID) numbers. Before citing these studies, you must make sure that they meet the
Agency's acceptance criteria (attached to the DCI).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
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comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal concentration.
You have two options for submitting a CSF: (1) accept the standard certified limits (see 40 CFR
§158.175) or (2) provide certified limits that are supported by the analysis of five batches. If you
choose the second option, you must submit or cite the data for the five batches along with a
certification statement as described in 40 CFR §158.175(e). A copy of the CSF is enclosed;
follow the instructions on its back.
e. Certification With Respect to Citation of Data. Complete and sign EPA form 8570-
34 and 8570-35 for each product.
4 COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5 WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data waiver
and time extension requests within 60 days. EPA will also try to respond to all 8-month
submissions with a final reregi strati on determination within 14 months after the RED has been
issued.
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REREGISTRATION ELIGIBILITY DECISION
Aluminum and Magnesium Phosphide
LIST A
CASES 0025 & 0645
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TABLE OF CONTENTS
ALUMINUM AND MAGNESIUM PHOSPHIDE REREGISTRATION ELIGIBILITY
DECISION TEAM i
ABSTRACT v
I. INTRODUCTION 7
II. CASE OVERVIEW 8
A. Chemical Overview 8
B. Use Profile 8
C. Estimated Usage of Pesticide 12
D. Data Requirements 18
E. Regulatory History 18
III. SCIENCE ASSESSMENT 19
A. Physical Chemistry Assessment 19
1. Description of Chemical 19
2. Identification of Active Ingredient 20
3. Manufacturing-Use Products 20
B. Human Health Assessment 20
1. Hazard Assessment 20
a. Acute Toxicity 21
b. Subchronic Toxicity 22
c. Chronic Toxicity and Carcinogenicity 23
d. Developmental Toxicity 24
e. Reproductive Toxicity 25
f. Mutagenicity 25
g. Metabolism 28
h. Dermal Absorption 28
i. Neurotoxicity 29
j. Epidemiological Information 31
2. Dose Response Assessment 34
a. Determination of Susceptibility 34
b. Toxicological Endpoints for Use in Risk Assessment 35
(1) Acute Reference Dose (RfD) 35
(2) Chronic Reference Dose 37
(3) Occupational and Residential Dermal Exposure 38
(4) Short Term Inhalation (1 day to 1 week) 38
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(5) Intermediate Term Inhalation (7 days to several
months) 38
(6) Long Term Inhalation (several months to lifetime) . . 39
(7) Dermal Absorption 39
(8) Classification of Carcinogenic Potential 39
3. Exposure Assessment 40
a. Dietary Exposure 40
b. Dietary Exposure from Drinking Water 52
c. Occupational and Residential Exposure 52
4. Risk Assessment 62
a. Dietary Risk Assessment 62
b. Cumulative Risk 67
c. Effects to the Endocrine System 67
d. Occupational and Residential Risk Assessment 68
e. Additional Occupational/Residential Exposure Studies 77
f. Short Term Residential Risk 77
C. Environmental Assessment 77
1. Environmental Fate and Transport Assessment 78
2. Surface and Ground Water Assessments 79
3. Exposure and Risk Characterization 79
a. General 79
b. Endangered Species 79
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 80
A. Determination of Eligibility 80
B. Determination of Eligibility Decision 81
1. Eligibility Decision 81
2. Eligible and Ineligible Uses 81
C. Regulatory Position 81
1. Food Quality Protection Act Findings 81
a. Determination of Safety for U.S. Population 81
b. Determination of Safety for Infants and Children 82
c. Effects to the Endocrine System 83
2. Alternatives and Benefits Analysis 84
3. Tolerance Reassessment 84
4. Codex Harmonization 89
5. Summary of Risk Management Decisions 90
a. Human Health 90
(1) Dietary 90
(2) Worker (Mixer/Loader/Applicator) 90
(3) Bystanders 91
(4) Public Comment and Stakeholder Meeting Process . . 92
(5) Proposed Risk Mitigation Measures 92
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b. Environmental/Ecological Effects 101
c. Restricted Use Classification 102
d. Endangered Species Statement 102
e. Occupational Labeling Rationale 102
V. ACTIONS REQUIRED OF REGISTRANTS 103
A. Manufacturing-Use Products 103
B. End-Use Products 103
1. Additional Product-Specific Data Requirements 103
2. Labeling Requirements for End-Use Products 104
C. Required Labeling Changes Summary Table 104
D. Existing Stocks 108
VI. APPENDICES 109
A. Table of Use Patterns Subject to Reregistration Ill
B. Table of the Generic Data Requirements and Studies Used to Make the
Reregistration Decision 113
C. Citations Considered to be Part of the Data Base Supporting the Reregistration
Decision 135
D. Product Specific Data Call-In 147
1. Product Specific Chemical Status Sheets 161
2. Data Call-in Response Form for the Product Specific Data(Form A
inserts) Plus Instructions 163
Sample Response Form for the Product Specific Data Call-In(Form A) 164
3. Product Specific Requirement Status and Registrant's Response Forms
(Form B inserts) and Instructions 165
Sample Requirements Status and Registrant's Response Form for the Product Specific
Data Call-In(Form B) 168
4. EPA Batching of End-Use Products for Meeting Data Requirements for
Reregistration 173
5. List of All Registrants Sent This Data Call-in (insert) Notice .... 177
E. List of Available Related Documents and Electronically Available Forms. 178
F. Review of Incident Data 183
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ALUMINUM AND MAGNESIUM PHOSPHIDE REREGISTRATION ELIGIBILITY
DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
William L. Gross
Alan Halvorson
Herbicide & Insecticide Branch
Economic Analysis Branch
Environmental Fate and Effects Risk Assessment
Norman B. Birchfield
James A. Hetrick
Richard J. Mahler
Joseph R. Sylvester
Health Effects Risk Assessment
Paul I. Lewis
Steven A. Knizner
Julianna F. Cruz
Stanley B. Gross
David E. FIrdy
Tracy L. Keigwin
Timothy Leighton
Kelly M. O'Rourke
Registration Support
William W. Jacobs
Dennis McNeilly
Risk Management
Environmental Risk Branch I
Environmental Risk Branch I
Environmental Risk Branch I
Environmental Risk Branch I
Risk Characterization and Analysis Branch
Risk Characterization and Analysis Branch
Risk Characterization and Analysis Branch
Toxicology Branch II
Chemistry and Exposure Branch II
Chemistry and Exposure Branch I
Chemistry and Exposure Branch I
Chemistry and Exposure Branch I
Insecticide-Rodenticide Branch
Insecticide-Rodenticide Branch
Mark A. Hartman
Reregi strati on Branch II
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (D WEL) The DWEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FAO/WHO Food and Agriculture Organization/World Health Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FQPA Food Quality Protection Act
FOB Functional Observation Battery
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HOT Highest Dose Tested
HIARC Hazard Identification and Review Committee
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
of the test animals when administered by the route indicated (oral, dermal, inhalation). It is
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
/-tg/g Micrograms Per Gram
fj,g/L Micrograms per liter
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
ill
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GLOSSARY OF TERMS AND ABBREVIATIONS
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NOEC No Observable Effect Concentration
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
Pa Pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q/ The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
RUP Restricted Use Pesticide
SLN Special Local Need (Registrations Under Section 24 © of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
WP Wettable Powder
WPS Worker Protection Standard
IV
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ABSTRACT
The U. S. Environmental Protection Agency has completed its reregistration eligibility decision
for the pesticides aluminum and magnesium phosphide. This decision includes a comprehensive
reassessment of the required target data and the use patterns of currently registered products.
Aluminum and magnesium phosphide are registered as fumigants on a wide variety of raw
agricultural commodities including stored grain and vegetable crops, stored processed foods and non-
food commodities. Typical storage structures include silos, bins and railcars. These pesticides are
also registered for use in animal dens and burrows. Both aluminum and magnesium phosphide act
as broad spectrum insecticides and as rodenticides for controlling small mammalian pests. Aluminum
and magnesium phosphide are formulated as pellets, tablets, impregnated materials and dusts. The
Aluminum and Magnesium Phosphide Task Force is supporting the reregistration of all currently
registered uses.
Aluminum and magnesium phosphide react with the moisture in the atmosphere to produce
phosphine gas which is the substance that is active as a pesticide. For this reason, and given their
common use sites and methods of application, the Agency is considering these two pesticides together
for the purposes of risk assessment and reregistration.
The Agency has determined that all uses of aluminum phosphide and magnesium phosphide
as specified in this document require mitigation of the risks associated with the exposure to these
pesticides. The Agency will conduct a public process to identify the best ways to reduce the risks
associated with aluminum and magnesium phosphide exposure. This process will include a public
comment period and a stakeholder meeting. Following the conclusion of this process, the Agency
will make a final determination on the mitigation measures that must be adopted in order for products
containing aluminum and magnesium phosphide to be eligible for reregistration.
The Food Quality Protection Act of 1996 (FQPA) amended the FFDCA by setting a new
safely standard for the establishment of tolerances. In determining whether a tolerance meets the new
safety standard, section 408 (b)(2)(C) directs the Agency to consider information concerning the
susceptibility of infants and children to pesticide residues in food, and available information
concerning aggregate exposure to infants and children of such residues, as well as the potential for
cumulative effects from pesticide residues and other substances that have common mechanisms of
toxicity. Further, the FQPA amendments require the Agency to apply a 10-fold safety factor to
protect infants and children unless reliable data demonstrate that the factor can be reduced or
removed.
In determining whether to retain, reduce, or remove the 10X FQPA safety factor for infants
and children, the Agency uses a weight of evidence approach taking into account the completeness
and adequacy of the toxicity data base and the nature and severity of the effects observed in pre- and
post-natal studies. The data provided no indication of increased susceptibility of rats to in utero or
postnatal exposure to aluminum or magnesium phosphide. In addition, exposure assessments do not
indicate a concern for a potential risk to infants and children because residues of phosphine are not
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expected in food or drinking water and there is only a limited registered residential use at the present
time that the Agency has proposed to remove. Given these factors, the Agency determined that an
additional 1 OX safety factor is not necessary to protect infants and children, and that based on reliable
toxicology and exposure data, a lesser margin of safety will be safe for infants and children.
Regarding aggregate exposure, the Agency only considered dietary exposure from food
because drinking water exposure is not expected and there is only a limited residential use at the
present time that the Agency has proposed to remove. Since, as mentioned above, no residues of
phosphine gas are expected on food or in drinking water aggregate risk is not a concern. The Agency
also considered the possible risks associated with a related pesticide, zinc phosphide, which also
generates phosphine gas in this aggregate assessment. The RED for zinc phosphide determined that
an aggregate assessment for that chemical for the various possible sources of phosphine from its uses
was not warranted because the likelihood of exposure is very low/unlikely. Therefore, the
contribution of zinc phosphide to this aggregate assessment was negligible.
The Agency does not have, at this time, available data to determine whether aluminum,
magnesium and zinc phosphide have a common mechanism of toxicity with other substances.
Additionally, the Agency does not currently have the methodology to conduct a cumulative risk
assessment. For the purposes of this assessment, therefore, the Agency has not assumed that
aluminum and magnesium phosphide have a common mechanism of toxicity with other substances.
Given the use patterns and environmental fate characteristics of these pesticides, aluminum
and magnesium phosphide are not expected to pose a significant ecological risk to non-target
organisms or to water resources under most circumstances. The exception is potential risks to some
endangered species. Since one of the uses of these pesticides is as a burrow fumigant for the control
of rodents there is a concern that several endangered or threatened species, such as the black-footed
ferret, could be present in burrows targeted for fumigation.
Given the high toxicity of aluminum and magnesium phosphide and potential risks posed to
occupational and residential bystanders, a number of mitigation measures are proposed by the
Agency. Aluminum and magnesium phosphide are methyl bromide alternatives. Furthermore, since
these pesticides have significant benefits and there are few if any viable alternatives besides methyl
bromide, the Agency believes that it is important that a broad stakeholder process be conducted to
discuss these measures and/or to develop other workable mitigation measures that adequately protect
occupational and residential bystanders. The proposals described in this document constitute the
Agency's preliminary thoughts on the best ways to reduce the risks of concern. These measures are
to be discussed as part of the public review and stakeholder meeting process mentioned above.
VI
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended to
accelerate the reregi strati on of products with active ingredients registered prior to November 1,1984.
There are five phases to the reregi strati on process. The first four phases of the process focus on
identification of data requirements to support the reregi strati on of an active ingredient and the
generation and submission of data to fulfill the requirements. The fifth phase is a review by the U.S.
Environmental Protection Agency ("the Agency") of all data submitted to support reregi strati on.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether
pesticides containing such active ingredients are eligible for reregistration" before calling in data on
products and either reregistering products or taking "other appropriate regulatory action." Thus,
reregistration involves a thorough review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to reassess the potential hazards arising from the
currently registered uses of the pesticide; to determine the need for additional data on health and
environmental effects; and to determine whether the pesticide meets the "no unreasonable adverse
effects" criterion of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
was signed into law. FQPA amends both the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7
U.S.C.136 et seq. The FQPA amendments went into effect immediately. As a result, EPA is
embarking on an intensive process, including consultation with registrants, States, and other
interested stakeholders, to make decisions on the new policies and procedures that will be appropriate
as a result of enactment of the FQPA. This process will include a more in-depth analysis of the new
safety standard and how it should be applied to both food and non-food pesticide applications. The
FQPA did not, however, amend any of the existing reregistration deadlines in Section 4 of FIFRA.
The Agency will therefore continue its ongoing reregistration program, while it continues to
determine how best to implement the FQPA.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of aluminum and magnesium phosphide. The document consists of six sections.
Section I is the introduction. Section II describes aluminum and magnesium phosphide, their uses,
data requirements, and regulatory history. Section III discusses the human health and environmental
assessments based on the data available to the Agency. Section IV presents the reregistration decision
for aluminum and magnesium phosphide. Section V discusses the reregistration requirements for
aluminum and magnesium phosphide. Finally, Section VI contains the Appendices which support this
Reregistration Eligibility Decision. Additional details concerning the Agency's review of applicable
data are available on request.
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II.
CASE OVERVIEW
A.
Chemical Overview
This Reregistration Eligibility Decision covers both aluminum and magnesium
phosphide. The following table provides an overview of these chemicals:
Table 1: Chemical Overview
Common Names
Chemical Names
Chemical Family
CAS Registry Numbers
OPP Chemical Codes
Empirical Formula
Trade and Other Names
Basic Manufacturers
Aluminum Phosphide
Aluminum Phosphide
Aluminum Phosphide
Inorganic compound
20859-73-8
066501
A1P
Fumtoxin, L-Fume, Tri-Tox
Fumiphos, Phostoxin, Fumex,
Gastoxin, Quik-Fume
Bernardo Chemical Ltd, Inc.
Degesch America, Inc.
Inventa Corporation
Midland Fumigant, Inc.
Pestcon Systems, Inc.
Magnesium Phosphide
Magnesium Phosphide
Magnesium Phosphide
Inorganic compound
12057-74-8
066504
Mg3P2
Fumi-Cell, Magnaphos,
Magtoxin
Degesch America, Inc.
Inventa Corporation
B.
Use Profile
Aluminum and magnesium phosphide are fumigants used primarily for indoor
fumigation of raw agricultural commodities, animal feeds, processed food commodities, and
non-food commodities in sealed containers or structures to control insects, and for outdoor
fumigation of burrows to control rodents and moles in non-domestic areas, noncropland, and
agricultural areas. Aluminum and magnesium phosphide also is used to control rodents which
can carry various diseases including sylvanic plague. In cases where the purpose of treatment
is to control for a vector-borne disease the use would be considered a public health use. The
following is information on currently registered uses, with an overview of use sites and
application methods. A detailed table of these uses of aluminum phosphide and magnesium
phosphide is in Appendix A.
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For aluminum phosphide:
Type of Pesticide: Insecticide; Rodenticide
Use Sites:
Nonfood and Related Areas:
Aluminum phosphide is registered for use on the following nonfood items and related
areas: temporarily stored nonfeed/nonfood commodities, commercial
storage/warehouse premises, silos, seeds, article treatments, agricultural uncultivated
areas, non-agricultural uncultivated areas, wide area public health uses (e.g., tires for
mosquito control or animal burrows for rodent control), and wood protection
treatment to seasoned forest products. It is also registered for use on stored furs,
feathers, hair, leather/leather hides, paper, textiles/fabrics/fibers, and tobacco.
Food and Related Areas:
Aluminum phosphide is registered for use on the following food/feed crops:
temporarily stored feed/food commodities, barley, buckwheat, corn, millet, oats, rice,
wild rice, rye, sorghum, triticale, wheat, peanuts, soybeans, vegetables, dates, figs,
almonds, brazil nuts, cashews, filberts, pecans, pistachios, walnuts, grass
forage/fodder/hay, popcorn, rape, sesame, cocoa, coffee, legume vegetables,
safflower, seeds, and sunflower. It is also registered for use in orchards, commercial
transportation facilities and commercial shipping containers, food processing plants
(nonfood contact), silos, commercial storehouses/warehouses, and grain/cereal/flour
bins and elevators. It is also used on diseased or empty beehives.
Processed Food:
Aluminum phosphide is registered for use on the following processed foods and
related areas: candy, cereal flour/bakery mixes, pasta/crackers, cereals, bagged
grain/cereal/flour, cheese/cheese byproducts, chocolate/chocolate byproducts, coffee,
processed/ground corn, cottonseed, dried egg yolk solids, dried fruits, herbs/spices,
livestock feed, malt/malt beverage, dried milk, dried non-dairy creamers, cured meat
products, nut meats, oats, rice, soybean flour, starch, sugar, tea, dried vegetables, and
yeast. It is also registered for use in commercial transportation facilities and
commercial shipping containers, in food processing plants (nonfood contact), silos,
commercial storehouses/warehouses, and grain/cereal/flour bins and elevators.
Target Pests: The pests that are controlled by aluminum phosphide are africanized
honey bee, almond moth, angoumois grain moth, bean weevil, diseased bees, cadelle,
cereal leaf beetle, cigarette beetle, confused flour beetle, dermestid beetles, driedfruit
beetle, driedfruit moth, european grain beetle, flat grain beetle, flatheaded grain beetle,
fruit flies, granary weevil, greater wax moth, hairy fungus beetle, hessian fly, honey
bee, Indian meal moth, khapra beetle, lesser grain borer, maize weevil, mediterranean
flour moth, mosquitos, pea weevil, pink bollworm, raisin moth, red flour beetle, rice
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weevil, rust red grain beetle, rusty grain beetle, sawtoothed grain beetle, spider
beetles, tobacco moth, tracheal mite, wax moth, yellow meal worm, chipmunks,
gophers, ground squirrels, house mice, marmot, meadow vole, mice, moles, norway
rats, prairie dogs, rodents, roof rats, woodchucks, and yellow-bellied marmot.
Formulation Types Registered: dust (57-60%), granular (55%), and
pelleted/tableted (55-60%)
Method, Rates and Timing of Application:
The type of formulation and method of application a handler selects are
dependent on the commodity and the structure being fumigated. In all cases, the
metal oxide is converted to phosphine gas when it reacts with atmospheric moisture.
A common method of application is to spread tablets or pellets along the surface of
a commodity by hand or to probe to the center through a pipe into the commodity.
In this case, tablets are usually preferred to pellets, since typically it takes five times
as many pellets as it does tablets to generate an equal quantity of phosphine gas (Allen
1993). Pellets may also be distributed into a commodity using a dispensing machine.
Dusts are used when pellets or tablets are prohibited (such as in processed foods or
when fumigating a large enclosure and a substantial amount of product is necessary).
Tablets and pellets may be prohibited by some processors due to a white dusty residue
of aluminum oxide that remains following the fumigation. Dusts are usually contained
in paper sachets or pouches. These pouches are often linked in blanket form or belt
form. A typical blanket contains 100 pouches which are unrolled by the applicator
before application. Trays may also be used to avoid aluminum oxide residues. In
such cases, tablets or pellets are placed in trays near the commodity and, hence, any
residues following the generation of the phosphine gas will remain in the tray.
Frequency of fumigation varies widely, and is dependent on the function of a given
facility or holding area, pest pressure, and length of storage. Rates of application vary
by pest and use sites with the highest rate being 5.847 Ib. per 10,000 cubic feet on a
variety of use sites.
Use Practice Limitations:
Some current labels include statements prohibiting application directly to
water or wetlands, to areas where surface water is present or to intertidal areas below
the mean high water mark. Some labels also require that the product be kept out of
lakes, streams, ponds, tidal marshes, and estuaries. Some also contain an endangered
species restriction. Many labels also prohibit the contamination of water, food or
feed.
10
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For magnesium phosphide:
Type of Pesticide: Insecticide; Rodenticide
Use Sites:
Nonfood and Related Areas:
Magnesium phosphide is registered for use on the following nonfood items and
related areas: agricultural uncultivated areas, non-agricultural uncultivated areas,
wide area public health uses, wood protection treatment to seasoned and unseasoned
forest products, and tobacco. It is also registered for use on stored furs, feathers, hair,
leather/leather hides, paper, textiles/fabrics/fibers, and nonfood article treatment.
Food and Related Areas:
Magnesium phosphide is registered for use on the following food/feed crops:
temporarily stored food/feed commodities, barley, field corn, millet, oats, rice, rye,
sorghum, triticale, wheat, peanuts, soybeans, vegetables, dates, almonds, brazil nuts,
cashews, filberts, pecans, pistachios, walnuts, pop corn, sesame, cocoa, coffee,
safflower, sunflower, and grass forage. It is also registered for use in commercial
transportation facilities, empty or full commercial shipping containers, in food
processing plants and on processing plant equipment, in empty containers used for
processed feed/food or raw agricultural commodities, in food marketing, storage and
distribution premises, and equipment/utensils therein. Further, it is used in empty or
full grain/cereal/flour bins/elevators/storage areas as well as used on diseased or
empty beehives.
Processed Food:
Magnesium phosphide is registered for use on the following processed foods and
related areas: temporarily stored food/feed commodities, candy, cereal flour/bakery
mixes, pasta/crackers, cheese/cheese byproducts, chocolate/chocolate byproducts,
processed coffee, processed corn, cottonseed, dried egg yolk solids, dried fruits,
herbs/spices, livestock feed, malt/malt beverage, dried milk, dried non-dairy creamers,
cured meat products, nut meats, oats, rice, soybean flour, sugar, tea, dried vegetables,
and yeast. It is also registered for use in commercial transportation facilities, empty
or full commercial shipping containers, in food processing plants and on processing
plant equipment, in empty containers used for processed feed/food or raw agricultural
commodities, in food marketing, storage and distribution premises, and
equipment/utensils therein as well as in empty or full grain/cereal/flour
bins/elevators/storage areas.
Target Pests: The pests that are controlled by magnesium phosphide are africanized
honey bee, almond moth, angoumois grain moth, bean weevil, diseased bees, cadelle,
cereal leaf beetle, cigarette beetle, confused flour beetle, dermestid beetles, driedfruit
beetle, driedfruit moth, european grain beetle, flat grain beetle, fruit flies, grain weevil,
granary weevil, greater wax moth, hairy fungus beetle, hessian fly, honey bee, Indian
11
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meal moth, khapra beetle, lesser grain borer, maize weevil, millers, mosquitos, pink
bollworm, raisin moth, red flour beetle, rice weevil, rust red flour beetle, rust red grain
beetle, rusty grain beetle, sawtoothed grain beetle, spider beetles, tobacco moth,
tracheal mite, yellow meal worm, chipmunks, gophers, ground squirrels, meadow
vole, mice, moles, norway rat, prairie dogs, roof rat, woodchuck, and yellow bellied
marmot.
Formulation Types Registered: impregnated material (56-66%) and
pelleted/tableted (66%)
Method and Rates of Application:
Refer to the discussion above regarding aluminum phosphide for information
about application methods. Rates of application vary by pest and use site, with the
highest rate being 3.197 Ib. per 10,000 cubic feet on a variety of use sites.
Use Practice Limitations:
Some current labels include statements prohibiting discharge of effluent
containing this pesticide into lakes, streams, ponds, estuaries, oceans, or public water,
and prohibiting discharge of effluent containing this pesticide into sewage systems
without notifying sewage treatment plant authorities. Some labels also prohibit
application directly to water or wetlands.
C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of
aluminum and magnesium phosphide. These estimates are derived from a variety of published
and proprietary sources available to the Agency. The data, reported on an aggregate and site
(crop) basis, reflect annual fluctuations in use patterns, and variability in using data from
various information sources.
Based on available pesticide survey usage information for 1987 through 1996,
estimated annual usage of aluminum phosphide is about 1.6 million pounds active ingredient
(a.i.). Major uses include fumigation of wheat, peanuts and stored corn. Other sites treated
include various other commodity sites, and numerous commercial and industrial sites. Usage
estimates for this chemical are not precise due to scarcity of usage data sources for post-
harvest agriculture and non-agriculture uses/sites.
Based on available pesticide survey usage information for 1987 through 1996,
estimated annual usage of magnesium phosphide is more than the 2 to 3 thousand pounds
active ingredient (a.i.) used in California. (Usage data in terms of pounds a.i. are not available
for sites other than in California.) Major uses include fumigation of almonds and other food
commodities. Various commercial and industrial sites are also treated. Detailed usage
analysis of this chemical is not possible, because of a scarcity of both post-harvest agricultural
12
-------
usage data and non-agricultural usage data.
Available use data for aluminum phosphide is presented in Table 2 below. No tabular
data is provided for magnesium phosphide given the scarcity of use information for this
chemical, as mentioned above.
13
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Table 2: Estimated Annual Use of Aluminum Phosphide
Site
Almonds (1000 acres)
Almonds (*)
Corn for Consumption
-empty bin (mill Ib.)
-binned (mill Ib.)
Food Processing
Indoor
Non Classified
Oats for Consumption
-binned (mill Ib.)
Peanuts, stored (1)
- Oklahoma (tons)
- Texas
Pistachios
Recreational,
Outdoors
Residential Outdoor
Units
Grown
(000)
404
-
48,272
48,272
-
-
2,528
206,900
-
-
-
-
Units Treated
(000)
Wtd
Avg
-
-
3,379
17,378
-
-
253
33,104
-
-
-
-
Est
Max
-
-
4,827
21,722
-
-
379
49,656
-
-
-
-
% of Crop
Treated
Wtd
Avg
-
-
7%
36%
-
-
10%
16%
17%
-
-
-
Est
Max
-
-
10%
45%
-
-
15%
24%
26%
-
-
-
Lb AI Applied
(000)
Wtd
Avg
9
10
27
209
16
1
6
-
-
3
0
1
Est
Max
14
15
39
261
24
1
9
-
-
5
1
1
Average Application
Rate
Ibai/
unit/yr
-
-
0.008
0.012
-
-
0.03
-
-
-
-
-
#appl
/yr
-
-
1.0
1.0
-
-
1.0
1.0
1.0
-
-
-
Ib
ai/unit
/appl
-
-
0.008
0.012
-
-
0.03
-
-
-
-
-
-
States of Most Usage
(% of total Ib ai used on
site)
CA: 100%
CA: 100%
-
-
-
-
-
-
-
CA: 100%
-
-
14
-------
Site
Rice, binned (mill Ib.)
Walnuts (1000 acres)
Wheat for
Consumption (mill Ib)
- Empty bin (1)
- Binned
- Warehouses
Operations (1)
Whsale/Manuf/Hosp,
Outdoor (*)
Whsale/Manuf/Other,
Indoor (*)
CALIFORNIA ONLY
Alfalfa (*)
Apples (1000 acres)
Dry beans
Commodity
fumigation (*)
Fumigation, other (*)
Units
Grown
(000)
19,778
172
51,180
51,180
51,180
-
-
-
35
-
-
-
Units Treated
(000)
Wtd
Avg
593
-
3,583
19,193
8,189
-
-
-
-
-
-
-
Est
Max
890
-
5,118
23,031
10,748
-
-
-
-
-
-
-
% of Crop
Treated
Wtd
Avg
3%
-
7%
38%
16%
-
-
-
-
-
-
-
Est
Max
5%
-
10%
45%
21%
-
-
-
-
-
-
-
Lb AI Applied
(000)
Wtd
Avg
15
0
29
576
90
17
15
1
1
0
17
37
Est
Max
22
1
41
691
118
26
23
1
1
1
26
55
Average Application
Rate
Ibai/
unit/yr
0.02
-
0.008
0.030
0.011
-
-
-
-
-
-
-
#appl
/yr
2.5
-
1.0
2.5
1.0
-
-
-
-
-
-
-
Ib
ai/unit
/appl
0.01
-
0.008
0.012
0.011
-
-
-
-
-
-
-
States of Most Usage
(% of total Ib ai used on
site)
CA: 20%
CA:100%
-
-
-
-
-
-
-
15
-------
Site
Grape (1000 acres)
Landscape
maintenance (*)
Nursery /Greenhouse
(*)
Prunes (*)
Right-of-Way (*)
Safflower (*)
Storage area/ process
equipment (*)
Structural pest control
(*)
Sudangrass (*)
Vertebrate pest
control (*)
Wheat, forage (*)
TOTAL
Units
Grown
(000)
652
-
-
-
-
-
-
-
-
-
-
Units Treated
(000)
Wtd
Avg
-
-
-
-
-
-
-
-
-
-
-
Est
Max
-
-
-
-
-
-
-
-
-
-
-
% of Crop
Treated
Wtd
Avg
-
-
-
-
-
-
-
-
-
-
-
Est
Max
-
-
-
-
-
-
-
-
-
-
-
Lb AI Applied
(000)
Wtd
Avg
4
13
0
o
5
4
0
2
5
1
6
1
1,122
Est
Max
6
20
1
5
6
1
2
8
2
9
1
1,683
Average Application
Rate
Ibai/
unit/yr
-
-
-
-
-
-
-
-
-
-
-
#appl
/yr
-
-
-
-
-
-
-
-
-
-
-
Ib
ai/unit
/appl
-
-
-
-
-
-
-
-
-
-
-
States of Most Usage
(% of total Ib ai used on
site)
-
-
-
-
-
-
-
-
-
-
-
COLUMN HEADINGS
Wtd Ave = Weighted average, with the most recent years and more reliable data weighted more heavily.
16
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Est Max = Estimated maximum, which is estimated from available data.
Average application rates are calculated from the weighted averages.
NOTES ON TABLE DATA
(*) Units available for treatment and units treated, if given, are measured as volume, weight, area and/or miscellaneous units of the commodity/
site.
(1) Usage is in terms of phosphine, which consists of mostly aluminum phosphide but possibly also some magnesium phosphide.
- A dash (-) indicates that information on this site is NOT available in EPA sources or is insufficient.
- Usage data primarily covers 1987 - 1996.
- Calculations of the above numbers may not appear to agree because they are displayed as rounded:
to the nearest 1000 for acres treated or Ib. a.i. (Therefore 0 = < 500.)
to the nearest whole percentage point for % of crop treated. (Therefore 0% = < 0.5%.)
- Small usage (<500 Ibs a.i.) is indicated in sources for the following total U.S. sites: office/retail and government, outdoor.
- Small usage (<500 Ibs a.i.) is indicated in sources for the following CA sites: animal husbandry premises; apricots; artichokes; asparagus;
avocados; barley; beans, green; beehives; Bermuda grass; beverage crops; blackberries; bushberries; carrots; cherries; Chinese leafy vegetables/
greens; clover; commercial/institutional areas; com, forage/sweet; cotton; county agriculture commission sales; feed/food storage; figs; flavor-
ing/spices; food handling; forage/fodder grasses; fruits, dried; garlic; grapefruit; grasses, rye; kiwifruit; lemons; lettuce; nectarines;
olives; onions; oranges; orchards; ornamental turf; pasture; peaches; pears; peas; pecans; persimmons; plums; public health pest control; range-
land; raspberries; research commodities; rye; soil application; sorghum; strawberries; sugarbeets; sunflower; sweet potatoes; tangerines;
uncultivated areas; and vegetables, misc.
SOURCES -
- Proprietary EPA data, 1987-1996
- CA Use Reports, 1993-1994
-USDA/NASS, 1990-1995
- Commercial/Certified Pesticide Applicators Survey (CCPAS), Research Triangle Instil, 1993 data
- Oklahoma State Univ., Current Management Practices and Impact of Pesticide Loss in the Hard Red Wheat Post-Harvest System, 1992 data
- Oklahoma State Univ. and Texas A&M Univ., Use of Pest Management in Stored Peanuts in OK and TX, 1994 data
- Kevric Company, Market Analysis of Postharvest Pesticide Use, December 1997
17
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D. Data Requirements
Data required for the reregi strati on of aluminum and magnesium phosphide are
outlined in 40 CFR 158.150 through 158.740 for those uses supported by the registrant.
There have been two (2) data call-ins (DCI) for this chemical. The first issued on August 6,
1990, required product chemistry data. The second was issued April 6, 1993 for sub-chronic
neurotoxicity, chronic toxicity/oncogenicity, reproductive toxicity, rat dominant lethality, and
usage data. Appendix B includes all data requirements identified by the Agency which are
required to support reregi strati on of currently registered uses.
E. Regulatory History
Aluminum Phosphide
Development of aluminum phosphide as a source of phosphine gas for fumigation was
pioneered by the German company Degesch. Aluminum phosphide first was registered as a
pesticide in the U.S. in 1958 to Hollywood Termite Control Company, Inc. Although the
registrant's name was changed subsequently, the original U.S. aluminum phosphide
registration remains active. Currently there are 23 products containing aluminum phosphide
as the active ingredient registered as pesticides in the U.S. All of these aluminum phosphide
products have been classified as restricted use due to "Inhalation Hazard to Humans" (40
CFR, §152.175).
In October of 1981, EPA issued a Pesticide Registration Standard which discussed
safety data and labeling for products containing aluminum phosphide. EPA also issued a data
call-in associated with the Registration Standard for aluminum phosphide. Subsequently,
EPA's Office of Pesticide Programs issued PR Notice 84-5, a "LABEL IMPROVEMENT
PROGRAM FORFUMIGANTS" and PR Notice 85-6, which partially revised PR Notice 84-
5, but did not alter the portions of PR Notice 84-5 that pertained to aluminum phosphide.
In February of 1986, EPA announced an "Amended Reregi strati on Standard Process"
for pesticides containing aluminum phosphide as the active ingredient. That action was
precipitated by the Agency's having completed review of the data developed in response to
the data call-in associated with the 1981 Registration Standard. In October of 1986, EPA
announced another "Amended Reregi strati on Standard Process" which was intended to
supersede the 1981 Registration Standard, PR Notices 84-5 and 85-6, and the amended
standard for aluminum phosphide issued earlier in 1986. The second amended standard issued
in 1986 required additional data submissions and labeling changes for aluminum phosphide
and magnesium phosphide products.
40 CFR §180.225 identifies tolerances in raw agricultural commodities for residues
of phosphine gas resulting from postharvest applications and preharvest burrow treatments
with aluminum phosphide. 40 CFR §185.200 and §186.200 identify tolerances in processed
foods and animal feeds for phosphine resulting from use of aluminum phosphide.
18
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Magnesium Phosphide
Magnesium phosphide was first registered as a pesticide in the U.S. in 1979.
Currently, there are four pesticide products containing this active ingredient registered in the
U.S. All pesticide products containing magnesium phosphide as an active ingredient have
been classified for restricted use due to "Inhalation Hazard to Humans" (40 CFR, §152.175).
In 1982, EPA announced a Registration Standard for magnesium phosphide. PR
Notice 84-5 included labeling statements that were to be incorporated into the labeling of
magnesium phosphide products. PR Notice 85-6 did not alter these statements.
In February of 1986, EPA announced an "Amended Reregi strati on Standard Process"
for Magnesium Phosphide. The "Amended Reregi strati on Standard Process" of October
1986, which pertained to magnesium phosphide as well as to aluminum phosphide,
superseded the documents for the individual chemicals issued earlier in the same year, and
imposed additional data and labeling requirements for both metallic phosphides.
40 CFR §180.375 identifies tolerances in raw agricultural commodities for residues
of phosphine gas resulting from postharvest applications and preharvest burrow treatments
with magnesium phosphide. 40 CFR §185.3800 and §186.3800 identify tolerances in
processed foods and animal feeds for phosphine resulting from use of magnesium phosphide.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
1. Description of Chemical
Aluminum and magnesium phosphide are fumigants used primarily for indoor
fumigation of raw agricultural commodities, animal feeds, processed food
commodities, and non-food commodities in sealed containers or structures to control
insects, and for outdoor fumigation of burrows to control rodents and moles in non-
domestic areas, noncropland, and agricultural areas. The empirical formula,
molecular weight, CAS Registry number, and Shaughnessy number for aluminum
phosphide and magnesium phosphide are provided in Table 3.
19
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Table 3. Product Chemistry Description of Aluminum Phosphide and Magnesium Phosphide
Empirical Formula
Molecular Weight
CAS Registry Number
OPP Chemical Number
Aluminum Phosphide
A1P
57.96
20859-73-8
066501
Magnesium Phosphide
Mg3P2
134.9
12057-74-8
066504
2. Identification of Active Ingredient
Aluminum and magnesium phosphide are formulated with inert ingredients to
form grayish green or black to yellow granular or powdered solids with a
carbide/garlic odor and melting point of >1000 °C. Aluminum and magnesium
phosphide are relatively stable if protected from moisture, but readily release
phosphine gas upon contact with moisture from the air, water, or acids. Formulated
solid aluminum and magnesium phosphide are insoluble but highly reactive in water
and most solvents, and decompose releasing phosphine gas in acidic and alkaline
media. Since pure aluminum and magnesium phosphide is not stable, product
chemistry data has been waived in these cases.
3. Manufacturing-Use Products
There are no manufacturing-use products (MPs) registered under Shaughnessy
Nos. 066501 and 066504. The Agency has identified 28 aluminum phosphide end-
use products (EPs), and four magnesium phosphide EPs. The Agency has determined
that because there are no registered MPs containing aluminum or magnesium
phosphide as the sole active ingredient (TGAI), all registered EPs containing
aluminum or magnesium phosphide as the sole active ingredient are subject to a
reregi strati on eligibility decision.
Additional product-specific data are required to fulfill product chemistry data
for aluminum phosphide and magnesium phosphide EPs. The registrants must submit
the data required for the aluminum phosphide 55-60% EPs and magnesium phosphide
56-66% EPs, and either certify that the suppliers of beginning materials and the
manufacturing processes for the aluminum and magnesium phosphide EPs have not
changed since the last comprehensive product chemistry review or submit complete
updated product chemistry data packages.
B. Human Health Assessment
1. Hazard Assessment
The available toxicological database for aluminum and magnesium phosphide
is adequate and will support reregi strati on eligibility for currently registered uses. The
20
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test material of concern is phosphine gas which is the material with pesticidal
properties, when either aluminum or magnesium phosphide are used. Exposure
assessments do not indicate a concern for a potential dietary risk because residues of
phosphine are not expected in food or drinking water. Therefore, the typical
toxicological database for a food use chemical is not required.
Since the route of exposure of concern is inhalation many values are expressed
in ppm while others are reported in mg/L. The following table should be used as a
reference for conversion between these two units.
Table 4. Conversion of Parts per Million to Milligrams per Liter
farts per ivmuon
0.2
0.3
1
1.25
2.5
3
4.5
4.8
5
5.5
6.7
7.5
10
13
15
18
20
23
30
40
87
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
ppm
r\r\m
milligrams per loiter
0.0003
0.0004
0.001
0.002
0.0035
0.0042
0.006
0.0068
0.0071
0.008
0.009
0.011
0.014
0.018
0.021
0.025
0.028
0.032
0.042
0.057
n 1 17
mg/L
mg/L
mg/L
mg/L
mg/L
mg/L
mg/L
mg/L
mg/L
mg/L
mg/L
mg/L
mg/L
mg/L
mg/L
mg/L
mg/L
mg/L
mg/L
mg/L
mrr/T
a. Acute Toxicity
Phosphine gas produced from aluminum and magnesium phosphide
has been tested for acute toxicity by the inhalation route of exposure. No
significant exposure to phosphine gas are expected via the oral or dermal
routes. Results of the acute inhalation toxicity study (MRLD# 41377001)
found that the LC50 is greater than 11 ppm (approximately 0.014 mg/L),
placing it in Toxicity Category I. This was the highest dose tested. The
results obtained in this study satisfy the acute toxicity data requirements since
21
-------
inhalation exposure is the route of concern. In addition, a study by Waritz
and Brown (1969) showed phosphine to be a highly toxic gas with a 4-hour
LC50 = 0.014 mg/L (approximately 11 ppm). Given aluminum and magnesium
phosphide's use patterns and chemical characteristics, the other 81-series
guideline studies were waived for this chemical. Additional information
regarding these waivers is provided in the table below which summarizes the
results of the acute toxicology studies.
Table 5. Acute Toxicity of Phosphine Gas
Guideline
No.
81-1
81-2
81-3
81-4
81-5
81-6
Study Type
Acute Oral
Acute Dermal
Acute Inhalation
Primary Eye
Irritation
Primary Skin
Irritation
Dermal Sensitization
MRID
No study
No study
41377001
No study
No study
No study
Results
LC50>= 11
ppm (hdt)
—
—
—
Toxicity
Category
NA
NA
I
NA
NA
NA
NA = not applicable
b. Subchronic Toxicity
A 90-day inhalation study (MRID 41413101) was conducted with
male and female Fischer 344 rats exposed via inhalation to phosphine using
the following three different exposure regimens: I) 0, 0.3, 1.0 or 3.0 ppm, 6
hours/day, 5 days/week for 13 weeks; II) initiated on study Day 48 at 0 or 10
ppm (after 3 days of exposure 4 of 10 females died and therefore this group
was terminated); and III) initiated on study Day 75 with additional groups of
rats at 0 or 5 ppm for 15 days; exposure was terminated on study Day 90.
For each exposure regimen, recovery groups were included in the study and
these groups were sacrificed after 4 weeks of post-exposure observations.
In the 5 ppm for 15-day exposure regimen (regimen III), there were
no treatment-related effects on survival, body weight, food consumption,
ophthalmological or hematological parameters. No treatment-related
histopathological lesions were seen in either sex. Males exhibited statistically
22
-------
significant increases in alkaline phosphatase activity and blood urea nitrogen.
These increases, however, were not considered to be biologically significant
since: 1) similar increases were not seen in females ; 2) there were no
corroborative histopathological lesions in the kidneys; and 3) the effect did not
persist after recovery.
In rats exposed at 10 ppm for 3 days (regimen II), there was 80%
mortality in females but no mortality in males. Both sexes of rats exhibited
coagulative necrosis in the tubules of the kidneys and pulmonary congestion
was observed in the females that died. A LOEL of 10 ppm for four weeks
was based on lethality (80% deaths for females) due to the sharp dose-
response curve for acute toxicity.
In the 13-week exposure regimen (regimen I), there was no mortality
in either sex at any concentration tested. There was a transient decrease in
body weight gain accompanied by decreased food consumption. Red blood
cell counts, hemoglobin concentration, and hematocrit values were slightly
decreased in males at 3.0 ppm (at 4 weeks only), but no effects were observed
in these males at 13 weeks or in females at either interval. No
exposure-related gross or histologic findings were observed at levels up to
and including 3.0 ppm. A LOEL for subchronic exposure (13 weeks) was not
established in this study. The NOEL was 3 ppm (the HDT).
c. Chronic Toxicity and Carcinogenicity
Two year rat feeding study
In a two-year rat feeding study (Hackenberg, accession nos. 26937,
26938, 6000), diets were treated with aluminum phosphide pellets at 48 and
90 gm/metric ton, fumigated for 48 hours and 72 hours, mixed for 2 hours,
and then aerated for one hour. The feed was then stored frozen in small
sealed containers until used as laboratory rat feed. Sixteen separate batches
of feed were treated utilizing this methodology over the two-year period.
Samples of diet were taken to determine phosphine at the time the feed was
removed from the freezer. Phosphine levels ranged from 0.2 to 7.5 ppm and
averaged approximately 1 ppm. The amounts of phosphine that remained in
the feed offered to the rats as food was not measured (but would be expected
to be less because of dissipation). Therefore, the actual dosages in this study
are unknown. Two groups of 60 rats each (30 males and 30 females) were
used, one as the treatment group and the other as controls. Rats were
observed for effects on growth, food consumption, survival, morbidity,
hematology, blood chemistry and gross and microscopic pathology. No
differences were seen between the controls and the treated animals for any
toxicity parameter. No evidence of carcinogenicity was seen.
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The study was not considered an acceptable guideline study since
toxicity, resulting from phosphine residues, is not possible when aeration is
adequate. However, the study is acceptable for showing that toxic levels of
residues were not achieved even with the high fumigation treatment rates with
adequate aeration.
Two year rat inhalation study
In a chronic toxicity/carcinogenicity study (MRID 44415101),
Charles River Fischer CDF Rats (60/sex/group) were exposed to phosphine
under dynamic chamber conditions at levels of 0, 0.3, 1, or 3 ppm of
phosphine. The rats were kept under standard laboratory conditions,
observed twice daily, and sacrificed (10/sex/group) during week 52 of the
study. Body weights (weekly), food consumption (weekly), routine
hematologic, serum biochemical, and urinary analyses were all similar to
control animals.
There were no adverse effects observed for the initial twelve month
period. Body weights (taken weekly); food consumption (weekly); routine
hematologic, serum biochemical, and urinary analyses were all similar to
control animals. Ophthalmological observations, gross pathology, organ
weights, and histopathology indicated no adverse effects from the phosphine
exposures.
These results are based on an interim report for a two-year study
which should be completed by November 1998. Thus, the study is
considered upgradable, pending receipt and favorable review of the remaining
data. The NOEL for the 52-week period was 3.0 ppm, the HDT.
d. Developmental Toxicity
In a developmental study (MRID 41377002), CD derived Sprague
Dawley mated female rats (24-27/dosage group) were exposed in inhalation
chambers to concentrations of phosphine gas at 0, 0.03, 0.3, 3.0, 5.0, or 7.5
ppm, 6 hours per day on gestation days 6 through 15. The highest exposure
group (7.5 ppm) was terminated after 10 days of exposures due to high
mortalities (14/24). Treated females were observed twice daily for toxicity;
and body weights and food consumption were monitored throughout the
study. At day 20 post-coitus, females were sacrificed and examined for
corpora lutea, implantations, live and dead fetuses, and early and late
resorptions. Pups were identified, sexed, and examined for external
malformations and visceral and skeletal defects.
The females and their fetuses from the high dose group were not
examined for developmental effects. The only abnormalities observed were
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increased absorptions in litters (16 litters, 76 pups). Increased resorptions
were not seen in the 0.3, 3.0, or 5.0 ppm groups. All other observations were
comparable to the control females and pups. The maternal NOEL is 5 ppm
and the maternal LOEL is 7.5 ppm, based on the high incidence of maternal
deaths. The study was classified as acceptable and satisfies the requirements
for developmental toxicity in rats.
e. Reproductive Toxicity
This study, a requirement for a food-use pesticide, was waived since
residues of phosphine are not expected in food or drinking water.
f. Mutagenicity
Gene Mutations
In a Salmonella typhimurium reverse gene mutation assay (MRTD
41434301), the test was negative with hydrogen phosphide (PH3) in all
strains up to cytotoxic concentrations (>488 ppm/plate +/-S9).
Chromosome Aberrations
In an in vitro cytogenetic assay with Chinese hamster ovary (CHO)
cells (MRID No. 41434302) phosphine was positive at 2500 and 5000 ppm
without S9 activation. This resulted in a significant, but not dose-related
increases in the frequency of cells with structural chromosome aberrations.
Significant clastogenic effects were also noted at 2500 ppm with S9
activation, but not at the highest dose tested (5000 ppm). Although there are
limitations in this study, it is considered acceptable for regulatory purposes
because of the apparent induction of chromosomal damage by phosphine at
non-cytotoxic doses.
Other Genotoxic Mechanisms
In an in vivo unscheduled DNA Synthesis (UDS) in primary rat
hepatocytes (MRID No. 42788101), the test was negative in male Fischer rats
exposed via inhalation to phosphine gas doses of 0, 4.8, 13, 18, or 23 ppm
(equiv. to 0, 11.4, 30.8, 42.6 or 54.5 mg/m3, respectively) for 6 hours. Overt
toxicity (i.e., difficulty in breathing), but no target cell cytotoxicity, was
observed at the highest dose tested.
Occupational Exposure Mutagenicity Studies
In a human genotoxicity study (Garry et al, 1989), an analysis of
chromosome aberrations and sister chromatid exchanges (SCE) in peripheral
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lymphocytes in workers was conducted. The following groups were studied:
a) workers exposed to phosphine alone;
b) workers exposed to phosphine and other pesticides;
c) workers exposed to other pesticides and fumigants;
d) state grain workers, and;
e) controls.
Lymphocytes were also exposed to phosphine in vitro at different
concentrations and chromosome aberrations were analyzed at different times
after exposure.
Male fumigant applicators who, 6 weeks to 3 months earlier, were
exposed to phosphine and other pesticides had significantly increased stable
chromosome rearrangements, primarily translocations in G-banded
lymphocytes. There was no increase in sister chromatid exchanges due to
fumigation activities. Less stable aberrations, including chromatid deletions
and gaps, were significantly increased only during the application season, but
not at this later time point. During fumigant application, measured exposure
to phosphine exceeded accepted national standards.
Several limitations are noted in this study. First, the mix of exposures
in the different groups was not adequately documented. Second, there was
no effort to account for whether mitosis was halted in early phases of division
or after several mitotic cycles. This is important because many types of
chromosome alterations are unstable in that they are lost during the process
of cell division, and/or the cells containing the aberration fail to divide or are
otherwise killed. Third, there were no SCE differences in the exposure
groups. SCE damages should have paralleled chromosomal aberrations.
Based on the findings reported by Garry et al. (1989) that pesticide
applicators exposed to phosphine had increased levels of chromosome
damage, the Agency sponsored a series of acute (Kligerman et al.!994a) and
subacute (Kligerman et al.,1994b) inhalation cytogenetic studies with
phosphine. A summary of these studies follows.
(a) Phosphine was negative for the induction of micronucleated polychromatic
erythrocytes (MPE) in bone marrow cells and splenocytes and negative for the
induction of sister chromatid exchange or chromosomal aberrations in
splenocytes of CD-I male mice exposed by inhalation to 0, 5, 10 or 15 ppm
for 6 hours. Overt toxicity, manifested as lethargy and shallow breathing, was
seen at the highest dose tested. There was a dose-related and significant
reduction of splenocyte cell cycling at all levels, which indicates that
phosphine was cytotoxic to splenocytes. There was, however, no adverse
effect on bone marrow cells (MRTD 43315103).
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(b) As part of the Research Triangle Park-sponsored studies, male B6C3F1
mice and male F344 rats were exposed by inhalation to 0, 1.25, 2.5 or 5.0
ppm phosphine, 6 hours/day, 5 days/week over a 11-day period. Bone
marrow cells and/or peripheral blood lymphocytes were harvested and
examined for sister chromatid exchanges and chromosomal aberrations
(mouse and rat peripheral blood lymphocytes) and for MPEs (rat bone
marrow and mouse bone marrow and peripheral blood lymphocytes). In
addition, B6C3F1 males were exposed via inhalation to 0 or 5 ppm as above
over a 12-day period and mated with untreated females in a dominant lethal
assay. Results show that phosphine was not genotoxic at any endpoint.
While there was no evidence that the test material reached the target sites in
potentially genotoxic concentrations, dosing was considered adequate based
on the data from other submitted guideline studies (MRID 43315101).
Non-guideline studies
Additional in vivo data summarized below were available for review:
a) Following subchronic inhalation exposure (0, 0.3, 1.0 or 4.5 ppm, 6 hours/
day, 5 days/week for 13 weeks) but not acute inhalation exposure (0 or 5.5
ppm, 2 weeks, 6 hours/day, 5 days/week for 2 weeks), phosphine at 4.5 ppm
caused a statistically significant increase in MN induction in the spleen
lymphocytes and bone marrow cells of Balb-c male and female mice. There
was, however, no increase in gene mutations at the HPRT locus in the
recovered spleen lymphocytes (MRID 43315102).
b) After 6 hours of inhalation exposure, phosphine, at the highest dose tested
(19 ppm), induced a significant increase in chromosomal aberrations in the
bone marrow of Sprague Dawley male rats, but not in the female rats. The
effect is considered equivocal because increased chromosomal aberration
frequencies were only seen in high-dose males with severely reduced mitotic
indices (Mis). Females did not show increased chromosome aberrations and
did not have decreased Mis. There was also no effect on peripheral
lymphocytes (MRID No. Not assigned).
c) In an Australian study of workers exposed to phosphine (Barbosa, 1994),
31 phosphine fumigators and 21 controls, all employed at the New South
Wales Grain Corporation, were examined for micronucleus incidence in
peripheral blood lymphocytes and their concentrated urine was assessed for
mutagenicity in TA100 and TA98 strains of S. typhimurium. In addition,
serum bile acids were measured. The subjects, all males, were matched for
medication, X-ray exposure within the past year, and smoking habits. There
was no indication how often the fumigators were exposed, the most recent
exposure date, or the length of employment of the various fumigators. No
individual data were presented to identify if certain individuals showed
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unusually high micronuclei incidence, or presence of mutagens in the urine.
For analysis, urine samples were concentrated 75-fold and the
procedure of Yamaski and Ames (1977) was used to test mutagenicity to
TA100 and TA98 in the presence or absence of metabolic activation (S9). No
increase in the mutagenicity of urine from the fumigators (N=-27) vs controls
(N=-19) in this assay was observed. Similarly, no changes related to
phosphine exposure were observed in serum bile acids. Cholesterol and some
liver enzymes (gamma-glutamyl transferase) were elevated in the exposed
group.
Micronuclei formation was measured in isolated peripheral blood
lymphocytes cultured for 44 hours in the presence of phytohemagglutinin to
stimulate mitosis, arrested at metaphase with cytochalasin-B, and harvested
by cytocentrifugation after 72 hours in culture. The micronucleus incidence
was comparable among the fumigators and the control groups (overall MI for
fumigators = 6.9 vs 7.1 for controls).
Conclusion:
Phosphine is not mutagenic in bacteria but is clastogenic in vitro.
Both the negative Ames test and the positive Chinese hamster ovary cell
chromosome assay are consistent with the in vitro test results for zinc
phosphide. Zinc phosphide also produces phosphine gas as its active agent.
Studies conducted in vivo indicate that phosphine is not clastogenic in mice
or rats and does not cause dominant lethal mutations in mice following acute
exposures for up to 2 weeks. There is, however, evidence that inhalation
exposures of phosphine for up to 13 weeks induced significant clastogenic
and/or aneuploidogenic effects in male and female mice. The biological
relevance of this finding cannot be fully ascertained until the results of the 2-
year rat inhalation study currently underway are submitted and reviewed.
However, a one-year interim report reviewed by the Agency indicated no
concerns. The acceptable studies satisfy the pre-1991 mutagenicity initial
testing battery guidelines. No further testing is required at this time.
g. Metabolism
No studies were submitted nor required.
h. Dermal Absorption
Because the route of exposure anticipated for aluminum and
magnesium phosphide is inhalation, the Agency does not expect significant
dermal exposure. Therefore, dermal absorption studies are not required.
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i. Neurotoxicity
Acute
In an acute neurotoxicity study (MRID 44139001), 11 Crl:CD®BR
VAF/Plus® rats/sex/exposure group were exposed to 0, 20, 30, or 40 ppm of
phosphine (1% a.i. in nitrogen) for four hours. Each treatment group was
exposed via inhalation on a different day, with the first exposure occurring six
days prior to the final exposure. Eleven rats/sex/exposure group were
selected for functional observational battery (FOB) and motor activity (MA)
testing prior to and following exposure, and on days 7 and 14 post-exposure;
six rats/sex/exposure group were perfused for neuropathology.
All animals survived to scheduled termination. There were no
exposure-related clinical signs. FOB and MA parameters were characterized
by variability both within and among control and exposed groups; this
variability (which may be partly due to the unbalanced treatment schedule)
confounded interpretation of some of the results.
Palpebral closure was noted in some exposed groups on day 1 and was
significant in females exposed to 30 and 40 ppm and in males at 20 and 40
ppm. Body temperatures were significantly lowered for males and females on
day 1 in all exposure groups. The remainder of the differences in the FOB
parameters were random statistical variations that occurred both pre- and
post-test, were not dose related, or were not consistent between the sexes.
Motor activity (horizontal, vertical, total distance, and stereotypic
time) was decreased at 20, 30, and 40 ppm, primarily during the 10 and 20
minute post-exposure time intervals (data comparing motor activity for the
entire 30-minute assessment period was neither presented nor analyzed).
With one exception, these reductions no longer occurred at 7 or 14 days after
exposure. For males during the first 10-minute post-exposure interval,
horizontal activity decreased significantly by 76.4, 71.7, and 83.8% in the 20,
30, and 40 ppm groups, respectively. Males in the 20 ppm group had the
following decreases in horizontal activity: 76.4%, 77.6% (both statistically
significant), and 89.4% (non-statistically significant) during the 10,20, and 30
minute intervals, respectively. For females during the first 10-minute post-
exposure interval, horizontal activity decreased significantly by 71.3,48.0, and
83.5% in the 20, 30, and 40 ppm groups, respectively. Females in the 20 ppm
group had the following decreases in horizontal activity: 71.3%, 85.8% (both
significant), and 54.1% (non-statistically significant) during the 10,20, and 30
minute intervals, respectively. Similar decreases occurred for both sexes for
vertical activity, total distance, and stereotypic time. No phosphine-related
neuropathological changes were observed in any exposure group. Significant
increases in absolute and relative (body and brain weights) adrenal gland
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weights in males from the 40 ppm group were of questionable biological
significance and did not show a concentration-response relationship.
Major deficiencies in study design and reporting, along with the
absence of appropriate positive control data, raise questions about the
conduct of this study. However, the significant decrease in temperature and
motor activity, seen at all exposure levels in spite of the flaws in the study, are
considered treatment-related.
The LOEL for neurobehavioral findings is 20 ppm based on decreased
body temperatures and decreased motor activity in males and females. For
acute neurotoxicity the NOEL is <20 ppm. Based on lack of systemic
toxicity, the NOEL for systemic toxicity is 40 ppm. This acute inhalation
neurotoxicity study is classified unacceptable and does not satisfy the
guideline requirement for an acute inhalation neurotoxicity study (81-8) in
rats. However, the study is upgradable. An upgraded study was received by
the Agency in September 1998 and is currently being reviewed.
Subchronic
In a subchronic inhalation neurotoxicity study (MRTD 44210401), 16
Crl: CD®BR VAF/Plus® rats/sex/exposure group were exposed to phosphine
(1% a.i. in nitrogen) for six hours/day, 5 days/week, for approximately 90
days at 0, 0.3, 1, or 3 ppm. An additional six rats/sex were assigned to the 0
and 3 ppm groups for a two-week recovery group. Eleven rats/sex/exposure
group were assigned for neurobehavioral evaluations. Six of the eleven
rats/sex/exposure group were designated for neuropathological evaluations.
No exposure-related deaths occurred in this study. Body weights
were slightly higher in high-concentration males (2.4%) and females (1.2%)
after 13 weeks of treatment, and became equal or less than the control body
weights after the 2 week recovery period. Palpebral closure was consistently
increased in high-concentration animals compared to controls. The increase
was significant (p < 0.05) in high-concentration males at week 4 and was
exposure related. The increased palpebral closure in high-concentration
females was not significantly different from the control group. The incidence
of high-concentration males found sleeping was consistently higher than the
controls and was significantly higher (p < 0.05) at week 4. The sleep incidence
in males showed an exposure effect at weeks 4 and 13. A similar trend was
seen in females, but the differences were not statistically significant. Body
temperatures of high-concentration males were consistently lower than the
controls and reached statistical significance (p < 0.05) at week 13. The
decreased body temperature was exposure-related at weeks 4 and 13.
Females did not show a treatment-related change in body temperature. The
horizontal and vertical motor activities were significantly lower in high-
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concentration males than the control group at week 13, and were consistently,
but not significantly lower at other time intervals. Motor activity
measurements in females were compromised by high variations and significant
decreases in the high-concentration group at the pretest interval. There were
no treatment-related findings at necropsy or during the neurohistopathological
examination of collected tissues.
The effects seen in high-concentration males that could be treatment-
related are slight, but are consistent and mutually supportive. Effects in
females either did not occur, were not statistically significant, or were
compromised by variations in pretest measurements. Due to the equivocal
nature of the effects seen in high-concentration males, and the lack of effects
seen in females, the tentative NOEL for system!c/neurobehavioral findings is
3.0 ppm for males and females and a LOEL was not determined in this study.
Since the procedures used in this study have not been validated, and positive
effects may be obscured by insensitive methods, the NOEL is tentative and
will be re-evaluated upon receipt of information requested from the sponsor.
This subchronic neurotoxicity study is classified unacceptable and does not
satisfy the guideline requirement for a subchronic neurotoxicity inhalation
study (82-7) in rats. However, the study is upgradable. An upgraded study
was received by the Agency in September 1998 and is being reviewed.
j. Epidemiological Information
The following data bases have been searched for the poisoning
incident data on the active ingredient aluminum phosphide:
1) OPP Incident Data System (IDS) - This database contains reports of
incidents from various sources, including registrants, other federal and state
health and environmental agencies and individual consumers, which have been
submitted to OPP since 1992.
2) California Department of Food and Agriculture (replaced by the
Department of Pesticide Regulation in 1991) - California has collected
uniform data on suspected pesticide poisonings since 1982. Physicians are
required, by statute, to report to their local health officer all occurrences of
illness suspected of being related to exposure to pesticides. The majority of
the incidents involve workers. Information on exposure (worker activity),
type of illness (systemic, eye, skin, eye/skin, and respiratory), likelihood of a
causal relationship, and number of days off work and in hospital are provided.
3) National Pesticide Telecommunications Network (NPTN) - NPTN is a
toll-free information service supported by OPP. A ranking of the top 200
active ingredients for which telephone calls were received during calendar
years 1984-1991, inclusive, has been prepared. The total number of calls was
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tabulated for the categories; humans, animals, calls, incidents and others.
Detailed descriptions of 166 cases submitted to the California
Pesticide Illness Surveillance Program (1982-1994) were reviewed. In 162
of these cases, aluminum phosphide was used alone and was judged to be
responsible for the health effects. Only cases with a definite, probable or
possible relationship were reviewed. A review of these cases shows that the
majority of cases appear to involve illnesses to workers who entered areas
previously treated with aluminum phosphide. These areas included buildings,
fields, tarps, and chambers. These incidents indicate that aluminum phosphide
is capable of causing serious illness after fumigation, including difficulty in
breathing, headache, nausea, vomiting, abdominal cramps, and even death.
From 1982-1994 aluminum phosphide was ranked 15th as a cause of systemic
poisoning, 7th as a cause for hospitalization, and 7th as the most frequent
cause of systemic poisoning among agricultural workers. Twenty-one
individuals were hospitalized between 1982 and 1994. A large proportion of
cases occurred when people returned to fumigated structures to reopen and
ventilate. Often, exposure results from lack of proper protective equipment
and inadequate ventilation before persons are allowed in or near the treated
area. Residential illness or death has largely resulted from accidental
exposure, product misuse, and proximity to facilities which regularly fumigate
with aluminum or magnesium phosphide. Instructions on proper disposal and
storage of these products are critical to prevent explosions and fires that result
in damage to health and property.
Coincidental systemic and coincidental eye categories were associated
with the majority of the exposures reported in California. Such coincidental
cases typically occur when bystanders are accidently exposed. Out of a total
of twenty-two systemic coincidental exposures, sixteen workers became ill
after their almond sorting building was fumigated the previous day.
Symptoms included headache, nausea, vomiting, chills, abdominal cramps,
weakness, dizziness, and difficulty breathing. Out of the twenty-five
coincidental eye exposures, fourteen workers experienced eye irritation after
their storage building was fumigated the previous weekend. Symptoms
included red and watery eyes, and nasal secretions. The other eleven workers
out of the twenty-five coincidental eye exposures had re-occurring eye
irritations while working in an almond/pistachio processing plant.
Detailed review of the types of activities associated with incidents
suggests a number of patterns that may be amenable to mitigation through
improved label warnings. Improper handling or disposal of aluminum
phosphide tablets has resulted in fires and explosions leading to eight incidents
involving 19 people. Workers responsible for opening fumigated structures
or removing tarps have been involved in 15 incidents. Applications to kill
gophers or squirrels have resulted in 13 incidents of poisoning. A detailed
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discussion of aluminum phosphide poisoning incidents is presented in
Appendix G.
Several specific incidents that have come to the Agency's attention
which have been allegedly related to phosphine are of special concern to the
agency.
On July 7,1991, EPA headquarters was notified by Region 8, Denver,
Colorado, of a potential grain fumigant use problem in North Dakota. In
August, 1989, a woman died that lived in close proximity to a grain
fumigation operation. Her husband was treated at a medical facility in
October, 1989 for possible organophosphate poisoning. The couple had
complained about the fumigation operation since December, 1985. The two
cases were based on: (1) a review of epidemiology, environmental, and health
case material referred to headquarters from the Denver Regional Toxicologist;
and (2) supplemental case files provided by State of North Dakota personnel.
Both of these cases were considered possible pesticide poisoning incidents,
based on information presented in the files, and using standard rankings
terminology for human poisoning incidents. In the first case, Mrs. O'Brien's
death, the role of heat and chronic grain dust exposure are unclear and her
death could have resulted from other factors. In the second case, possible
poisoning, Mr. O'Brien reported symptoms of loss of peripheral motor control
(uncontrollable shakiness of the hands and feet), diarrhea, headache, burning
gums, lips and teeth, skin irritation, dry mouth and throat, and watering eyes
during his hospitalization on October 7, 1989. These reported symptoms
were worse when the aerator of the fumigation facility was operating about
three hundred fifty feet from their home. October, 1989, had the highest
monthly use of aluminum phosphide. Based on the available evidence the
Agency concludes that both of these incidents were possibly related to
aluminum phosphide.
Garry et al. (1993) reported the suspicious death of a pregnant rural
woman who lived 30 yards from a large bunker-type grain storage facility.
Reportedly, the facility was not tightly sealed in contrast to standard practice.
The woman reportedly was removing laundry in here yard sometime between
8 p.m. and 9 p.m. the evening she died. Upon reentering her home she told
her husband that the odor was "real strong tonight". After her husband and
child went to bed in an upstairs bedroom the patient remained on the first
floor of the structure. Between 10:30 and 11 p.m. she visited her local
physician at his home stating to him that she was "dying". The physician
noted on examination that the patient was tachycardic, vomiting and lucid.
Clear frothy sputum began to emanate from her mouth and nostrils. She was
then transferred to a hospital where she suffered from cardiac arrest shortly
after midnight and died.
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2. Dose Response Assessment
a. Determination of Susceptibility
The Food Quality Protection Act of 1996 (FQPA) amended the
FFDCA by setting a new safety standard for the establishment of tolerances.
In determining whether a tolerance meets the new safety standard, section 408
(b)(2)(C) directs the Agency to consider information concerning the
susceptibility of infants and children to pesticide residues in food, and
available information concerning aggregate exposure to infants and children
of such residues, as well as the potential for cumulative effects from pesticide
residues and other substances that have common mechanisms of toxicity.
The FQPA amendments to section 408(b)(2)(C) require the Agency
to apply a 10-fold safety factor to protect infants and children unless reliable
data demonstrate that the factor can be reduced or removed. In determining
whether the safety factor should be retained, reduced, or removed, the Agency
considers all reliable data and makes a decision using a weight-of-evidence
approach, taking into account the completeness and adequacy of the toxicity
database, the nature and severity of the effects in pre- and post-natal studies,
and other information such as epidemiological data.
A prenatal inhalation developmental toxicity study in rats (MRTD
41377002) to determine susceptibility of infants and children to aluminum and
magnesium phosphide showed no increased susceptibility to infants and
children. No treatment-related effects were seen in maternal body weight,
body weight gain, food consumption, and reproduction parameters at
necropsy. Further, no developmental toxicity was seen. Thus it was
determined that there is no increased susceptibility following in utero
exposure to phosphine gas. (Hazard Identification And Review Committee
(HIARC), April 16, 1998 and June 2, 1998 meetings)
The complete toxicology data requirements for a food-use chemical
are not required for aluminum and magnesium phosphide since little phosphine
exposure is expected from the use pattern (i.e. fumigant). Any phosphine left
in fumigated commodities is expected to be removed by adequate aeration of
the commodities. Bound reaction products formed by reactions with
phosphine andbiological materials form innocuous phosphates. Therefore, the
Agency determined that additional toxicology studies are not required for this
chemical.
The FQPA Safety Factor Committee also addressed dietary (food and
water) and residential exposure considerations. Detectable residues in food
have been reported in field trials. However, these detections were attributed
to misapplication (pellets applied directly to wheat grain resulting in residues
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of up to 83 ppm after 24 hours of aeration). Residues of phosphine are not
expected with proper use of these chemicals. A drinking water risk
assessment was not performed for aluminum and magnesium phosphide since
there are no concerns for ground or surface water contamination from the use
of these chemicals. This will be discussed in more detail later in this
document. There is a limited registered residential use at the present time.
However, the Agency has proposed that this use be removed..
Therefore, the Agency concluded that the lOx factor for increased
susceptibility of infants and children (as required by FQPA) should be
removed based on the rationale provided below:
(A) there was no indication of increased susceptibility of rats following in
utero exposure to aluminum/magnesium phosphide; and
(B) exposure assessments do not indicate a concern for potential risk to
infants and children because: 1) residues of phosphine are not expected in
food; 2) there is no concern for ground or surface water contamination from
this use; and 3) there is a limited registered use at the present time which the
Agency has proposed that this use be removed.
b. Toxicological Endpoints for Use in Risk Assessment
Inhalation studies are not normally appropriate for oral (dietary) risk
assessments. However, inhalation studies were used in hazard identification
for aluminum and magnesium phosphide because: 1) the toxicology database
for this chemical was limited to studies conducted via the inhalation route
because this is the route of exposure expected for phosphine gas; 2) these are
the only studies in which the Agency can quantify the dosage of phosphine
exposed to laboratory animals; and 3) use of an inhalation "dose" provides a
conservative approach for oral risk assessments. Further, since the oral route
of exposure is not of concern, no oral-route studies have been required.
(HIARC April 16, 1998 and June 2, 1998 meetings)
(1) Acute Reference Dose (RfD)
The acute dietary endpoint is based upon the results of the 90-
day inhalation study (MRTD 41413101) described on pages 16-17 of
this document. The dose and endpoint for risk assessment was 5 ppm
= 0.007 mg/L= 1.8 mg/kg/day based on lack of treatment-related
effects following 15 days of exposure in that study. The 5 ppm
concentration is appropriate for this acute dietary risk assessment,
because: 1) no treatment-related effects were seen at this
concentration after 15 days of exposure; 2) no treatment-related
effects were seen at a lower concentration (3 ppm) after a longer (13
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weeks) duration of exposure; and 3) an oral study was not available
in the database because the expected route of exposure is inhalation.
In addition, this concentration (5 ppm) is comparable to the
concentration of 6.7 ppm derived by using the LOEL of 20 ppm
established in an acute neurotoxicity study in rats and an Uncertainty
Factor of 3 for the lack of a NOEL (i.e., 20 ppm -K3 = 6.7 ppm). The
Agency did not elect to use the acute neurotoxicity study since a
NOEL was not established in the study; instead, the acute
neurotoxicity study was used as a "co-critical" or "support" study. In
the acute study (MRID 44139001), Crl:CD rats
(11/sex/concentration) were exposed to phosphine at 0, 20, 30, or 40
ppm (1% a.i. nitrogen) for 4 hours. The LOEL for neurobehavioral
effects was 20 ppm (the lowest concentration tested) based on
decreased body temperature and decreased motor activity in both
sexes; a NOEL was not established.
Since an inhalation concentration was selected for oral dietary
risk assessment, the following route-to route extrapolation (i.e.,
inhalation to oral) was used for establishing the acute RfD in
mg/kg/day:
To convert the ppm to mg/L/day:
mg/L/day @ 25° C/101 kPa = (ppm) x Molecular Weight of Phosphine Gas
24,450 (Boyle's gas law)
mg/L/day = 5 ppm x 34 (MW} =0.007 mg/L/day
24,450
To convert mg/L/day to mg/kg/day:
mg/kg/day = Concentration (mg/L/day) x Absorption x Conversion Factor x Duration
of Exposure x Activity Factor
mg/kg/day = 0.007 mg/L/day x 1.0 x 47.0 x 6 hours x 1.0
Where:
0.007 mg/L/day = Concentration (NOEL)
1.0 = absorption factor (100%, default)
47.0=Conversion Factor [Respiratory Volume (7.15 L/hr) H- Body Weight (0.152 kg)].
1.0 = Activity Factor (1, animal default).
An Uncertainty Factor of 100 was applied which included 10X for intra-species variation
36
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and 10X for inter-species extrapolation.
Acute RfD = 1.8 mg/kg/dav = 0.018 mg/kg/day
100 (UF)
(2) Chronic Reference Dose
The chronic reference dose was selected from a 2-year
chronic/carcinogenicity inhalation study in rats (MRID 44415101)
which is fully described on page 18 of this document. The dose and
endpoint for risk assessment was a NOEL = 3 ppm = 0.004 mg/L =
1.13 mg/kg/day. The dose recommended for oral risk assessment is
based on an inhalation NOEL. Phosphine has been shown to be toxic
via the inhalation route. It is noted that the "dose" recommended is
conservative and is recommended as a worst case scenario.
Since an inhalation concentration was selected for oral dietary
risk assessment, the following route-to-route extrapolation (i.e.,
inhalation to oral) was used for establishing the chronic RfD in
mg/kg/day:
To convert the NOEL of 3 ppm to mg/L/day:
mg/L/day @ 25° C/101 kPa = ppm x Molecular Weight of Phosphine Gas
24,450 (Boyle's gas law)
mg/L/day = 3 ppm x 34 (MW^) =0.004 mg/L/day
24,450
To convert mg/L/day to mg/kg/day:
mg/kg/day = Concentration (mg/L/day) x Absorption x Conversion Factor x Duration
of Exposure x Activity factor
mg/kg/day = 0.004 mg/L/day x 1.0 x 47.0 x 6 hours x 1.0
Where:
0.004 mg/L/day = Concentration (NOEL)
1.0 = absorption factor (100%, default)
47.0=Conversion Factor [Respiratory Volume (7.15 L/hr) H- Body Weight (0.152 kg)].
1.0 = Activity Factor (1, animal default).
An Uncertainty Factor of 100 was applied which includes 10X for intra-species variation
37
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and 10X for inter-species extrapolation.
Chronic RfD = 1.13 mg/kg/dav =0.0113 mg/kg/day
100 (UF)
(3) Occupational and Residential Dermal Exposure
Based on the use pattern, the route of exposure of concern is
inhalation, not dermal. Consequently, doses and endpoints were not
selected for dermal risk assessments. Doses and endpoints were
selected only for inhalation exposure risk assessments since this is the
route of exposure of concern.
(4) Short Term Inhalation (1 day to 1 week)
The 90-day inhalation study (MRID 41413101) that was also
used as the basis of the acute dietary RfD was used as the basis for the
short term inhalation risk assessment. The dose selected for risk
assessment was 5 ppm based on the lack of treatment-related effects
following 15 days of exposure. This concentration is appropriate for
the exposure period of concern (i.e., 1- 7 days) since the treatment
was for 15 days and no treatment-related effects were observed at this
concentration. A margin of exposure (MOE) of 100 (10X for intra-
species variation and 10X for inter-species extrapolation) is adequate
for occupational exposure via the inhalation route. A risk assessment
is not required for residential exposure. There is a limited registered
residential use at the present time. However, the Agency has
proposed that this use be removed. Further, bystander risk is an issue
of concern and is addressed as part of the occupational risk
assessment.
(5) Intermediate Term Inhalation (7 days to several months)
The 90-day inhalation study (MRID 41413101) was also used
as the basis for the intermediate-term inhalation risk assessment. For
the sub-chronic exposure (90-days), the NOEL was 3 ppm (0.004
mg/L) based on the lack of treatment-related effects at the highest
concentration tested; a LOEL was not established. The study is
appropriate for the exposure period of concern because of the
duration of exposure (i.e., 90 days) and the NOEL of this study is
supported by a similar NOEL established in a 90-day neurotoxicity
study in rats (MRID 44210401). In that study, no treatment-related
effects were observed in survival, clinical signs, body weights,
neurobehavioral effects, or gross and histopathology in male and
female Crl:CD rats exposed to phosphine (1% a.i in nitrogen) at 0,
38
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0.3, 1 or 3 ppm, 6 hours/day, 5 days/week for approximately 90 days.
The NOEL was 3 ppm (HDT); a LOEL was not established. A MOE
of 100 (10X for intra-species variation and 10X for inter-species
extrapolation) is adequate for occupational exposure via the inhalation
route. A risk assessment is not required for residential exposure.
There is a limited registered residential use at the present time.
However, the Agency has proposed that this use be removed.
Further, bystander risk is an issue of concern and is addressed as part
of the occupational risk assessment.
(6) Long Term Inhalation (several months to lifetime)
The chronic toxicity/carcinogenicity inhalation study (MRTD
44415101) that was used as the basis of the chronic dietary RfD was
also used as the basis for the long-term inhalation exposure risk
assessment. The NOEL was 3 ppm (0.004 mg/L), the highest dose
tested. A MOE of 100 (10X for intra-species variation and 10X for
inter-species extrapolation) is adequate for occupational exposure via
the inhalation route. A risk assessment is not required for residential
exposure. There is a limited registered residential use at the present
time. However, the Agency has proposed that this use be removed..
Further, bystander risk is an issue of concern and is addressed as part
of the occupational risk assessment.
(7) Dermal Absorption
Because the route of exposure anticipated for aluminum and
magnesium phosphide is inhalation, the Agency does not expect
significant dermal exposure. Therefore, dermal absorption studies are
not required and no risk assessment is required for this route of
exposure.
(8) Classification of Carcinogenic Potential
The carcinogenic potential of aluminum and magnesium
phosphide has not been fully evaluated since the results of the two-
year carcinogen!city study is expected to be submitted in November,
1998. However, the interim results (52 weeks) do not show any
evidence of carcinogenicity even at the highest concentration tested.
In addition, the results of a non-guideline two-year feeding study in
which no evidence of carcinogenicity was seen in rats fed diets that
were treated with aluminum phosphide pellets (Accession nos. 26937,
26938 and 6000). Also, exposure assessments do not indicate a
concern for a potential dietary risk because residues of phosphine are
not expected in food. Thus the Agency does not believe that
39
-------
aluminum and magnesium phosphide pose a carcinogenic concern.
A summary of the endpoints for dietary, short-term
(inhalation), intermediate (inhalation), and long-term (inhalation)
exposures are provided below. The endpoints are the same for both
aluminum and magnesium phosphide since they are based upon
phosphine gas, the common active agent for both chemicals.
Table 6. Summary of Aluminum and Magnesium Phosphide Endpoints for Risk Assessments
EXPOSURE
SCENARIO
Acute Dietary
Chronic Dietary
Short-Intermediate or
Long-Term (Dermal)
Short Term
(Inhalation)
Intermediate
(Inhalation)
Long-Term
(Inhalation)
CONCENTRATION/
DOSE
1.8 mg/kg/day
converted from
5 ppm
UF=100
1.13 mg/kg/day
converted from
3 ppm
UF=100
None
0.007 mg/L
UF=100
NOEL=
0.004 mg/L
UF=100
NOEL=
0.004 mg/L
UF=100
ENDPOINT
No treatment-related effects after exposure for 15
days.
STUDY
15-Day exposure
regimen in a 90-day
inhalation - Rat
Acute RfD =0.018
No treatment-related effects after chronic (52
weeks) inhalation exposure.
Chronic Toxicity
Inhalation-Rat
Chronic RfD =0.0113
The use pattern does not indicate potential exposure via the dermal route.
Therefore, dermal risk assessments are not required.
No treatment-related effects after exposure for 15
days.
No evidence of toxicity at the highest tested
concentration.
No evidence of toxicity at the highest tested
concentration.
15-Day exposure
regiment in a 90-
day inhalation - Rat
90-Day Inhalation -
Rat
Chronic Toxicity
Inhalation - Rat
3. Exposure Assessment
a. Dietary Exposure From Food Sources
Tolerances are established, at levels ranging from 0.01 to 0.1 ppm, for
residues of the fumigant phosphine in/on several raw agricultural commodities
(RACs) from postharvest treatment with aluminum [40 CFR § 180.225(a)] and
magnesium [40 CFR §180.375(a)] phosphide. Tolerances of 0.01 ppm have
been established for residues of the fumigant phosphine in/on all RACs
resulting from preharvest treatment of pest burrows in agricultural and non-
40
-------
cropland areas with aluminum [40 CFR §180.225(b)] and magnesium [40
CFR §180.375(b)] phosphide. Tolerances of 0.01 ppm have been established
for residues of phosphine in processed food resulting from the use of
aluminum [40 CFR §185.200] and magnesium [40 CFR §185.3800]
phosphide. Tolerances of 0.1 ppm were established for residues of phosphine
in animal feeds resulting from the use of aluminum [40 CFR §186.200] and
magnesium [40 CFR §186.3800] phosphide. Tolerances are based in many
cases on field/storage trial residues. In most cases, residues were not
detectable and, therefore, limits of detection were used when establishing the
tolerances.
GLN 860.1200 (171-3V Directions for Use
There are currently 28 aluminum phosphide and four magnesium
phosphide end-use products (EPs) registered under FIFRA Section 3; there
are no Special Local Need (SLN) registrations under FIFRA Section 24(c).
A list of registered aluminum and magnesium phosphide EPs is presented
inAppendix G. (REFS 2/27/97)
Because the use of aluminum and magnesium phosphide results in the
release of phosphine, a highly toxic gas, all end-use products containing these
active ingredients are classified for restricted use and may be applied only by
or under the supervision of a certified applicator.
Registered sites: Aluminum and magnesium phosphide are registered
for fumigation of stored food and feed commodities to protect them from
damage by insects. Aluminum and magnesium phosphide are also registered
for outdoor fumigation of rodent burrows. Aluminum and magnesium
phosphide may be blended with bulk commodities which are not directly
consumed as foods. Commodities which can be directly consumed as food
must not be contaminated by direct contact with aluminum and magnesium
phosphide. Fumigation of these items requires the registered product be
placed in trays fastened to a support within the area to be fumigated or the use
of sachets, belts or blankets, as described in the use profile earlier in this
document.
Fumigation treatment period guideline: For all products, the
recommended length of fumigation is dependent on temperature. A guide for
determining the exposure period at various temperatures is presented in Table
7. In general, a short fumigation exposure period is required at high
temperatures. It may be necessary to lengthen the fumigation at lower
temperatures and relative humidities (or grain moisture) since insects are
difficult to control under these conditions. The lengths of time the target
pests are exposed to the phosphine via fumigation, listed in Table 7, are
minimum periods and it is recommended they not be shortened for any reason
41
-------
other than when it may be necessary to abort the scheduled fumigation.
Recommended application rates (current): Phosphine is a mobile gas
and will penetrate all parts of the storage structure. Most labels specify
dosage rates based upon the total volume of the space being treated (i.e., per
1,000 cu. ft.); some labels also specify dosage rates based on the amount of
a commodity the storage structure contains (i.e., per 1,000 bushels).
Aluminum and magnesium phosphide may be applied in the form of tablets,
pellets, bags, or sachets. The general recommended rates based on
formulation class are listed in Table 8. The specific recommended rates based
on types of fumigation for aluminum and magnesium phosphide are presented
in Tables 9 and 10, respectively.
Aeration of fumigated commodities: The following information
pertains what is found on current labels. To ensure that phosphine residues
will not exceed the established tolerances, fumigated commodities (except
tobacco) should be aerated for 48 hours prior to making them available to
consumers. This aeration entails the venting of the structure that has been
fumigated to slowly reduce the level of phosphine gas in the
structure/commodity. Tobacco should be aerated for at least 72 hours when
fumigated in hogsheads or until the phosphine concentration is below 0.3 ppm
and for at least 48 hours when fumigated in other containers. The labels
examined also specify that under no conditions should the formulations
containing the active ingredients be used so that they will contact any
processed food (except processed brewer's rice, malt, and corn grits stored in
breweries for use in the manufacture of beer). When plastic liners are used,
longer aeration periods are required to reduce the phosphine residue level to
0.3 ppm. As an alternative to these aeration periods, each container of a
treated commodity may be analyzed for residues using accepted analytical
methods. If residues are less than tolerance levels, then the commodity may
be shipped to the consumer regardless of the established holding periods.
Aluminum and magnesium phosphide are not to be directly mixed with
foods, feed, and raw agricultural products which may be used directly as
foods. All labels must include the restriction, "Under no conditions shall food,
feed, and/or raw agricultural commodities which may be used directly as
foods come into contact with aluminum or magnesium phosphide." The
status of reregi strati on requirements for each guideline topic is based on the
use patterns registered by all the registrants of aluminum and magnesium
phosphide.
42
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Table 7. Recommended Temperatures and Exposure Periods When Using Aluminum and
Magnesium Phosphide.
Temperatures To Which
Fumigants and Insects Are
Exposed
Below 40 F (5 C)
40-53 F (4-12 C)
54-59 F (12-15 C)
60-68 F (16-20 C)
Above 68 F (20 C)
Minimum Exposure Period For Fumigation By
Formulation
Pellets
Do not fumigate
6 days (144 hours)
4 days (96 hours)
3 days (72 hours)
2 days (48 hours)
Tablets
Do not fumigate
7 days (168 hours)
5 days (120 hours)
4 days (96 hours)
3 days (72 hours)
Bags or Sachets
Do not fumigate
14 days (336
hours)
7 days (168 hours)
4 days (96 hours)
3 days (72 hours)
Table 8. Recommended General Dosage Rates for Aluminum and Magnesium Phosphide
By Formulation.
Formulation
Pellets a
Tablets b
Bagsc
Sachets c
Recommended Dosage
(In Terms of Product)
Per 1,000 cu. ft.
100-725 pellets
20-145 tablets
2-13 bags
2-13 sachets
Per 1,000 Bushels
120-905 pellets
25-1 80 tablets
2- 16 bags
—
Each pellet weighs -0.6 g and releases -0.2 g of phosphine.
Each tablet weighs -3 g and releases -1 g of phosphine.
Bags and sachets each weigh -34 g and release -11 g of phosphine.
43
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Table 9.
Recommended Dosage Rates For Aluminum Phosphide By Type of Fumigation and Storage.
Type of Fumigation and
Storage
Space
Mills (including cereal and feed
mills), warehouses, and food-
processing plants
Bulk animal feeds (except nuts)
Bagged and packaged
commodities (grain, processed
foods, etc.) in sealable
enclosure
Dried and processed fruits
(including nuts and dates) and
nuts in bags or storage boxes
Peanuts
Stored tobacco
Bulk Stored Commodities
Vertical storage [including
large vertical silo bins which are
relatively gas tight or well-
constructed concrete bins]
Recommended Dosage (In Terms of Product)
Pellets a (55-60% P/T)
100-300 pellets/1,000 cu.
ft.
120-300 pellets/1,000
bushels
150-300 pellets/1,000 cu.
ft.
100-200 pellets/1,000 cu.
ft.
—
100-200 pellets/1,000 cu.
ft.
120-375 pellets/1,000
bushels
or
150-375 pellets/1,000 cu.
ft.
Tablets b (55-60% P/T)
20-60 tablets/1, 000 cu. ft.
60- 180 tablets/1, 000
bushels
30-90 tablets/1,000 cu. ft.
20-40 tablets/1, 000 cu. ft.
60-125 tablets/1,000 cu.
ft.
20-40 tablets/1, 000 cu. ft.
40- 180 tablets/1, 000
bushels
or
30-75 tablets/1,000 cu. ft.
Bags c (55-57% D)
(55-60% P/T)
(60% Impr)
2-6 bags/1, 000 cu. ft.
—
2-6 bags/1, 000 cu. ft.
2-6 bags/1, 000 cu. ft.
—
2-6 bags/1, 000 cu. ft.
2-7 bags/1, 000
bushels
or
2-6 bags/1, 000 cu. ft.
Sachets c (57%
Impr)
2-6 sachets/1,000 cu.
ft.
—
3-6 sachets/1,000 cu.
ft.
2-4 sachets/1,000 cu.
ft.
—
2-4 sachets/1,000 cu.
ft.
3-5 sachets/1,000 cu.
ft.
44
(continued; footnotes follow)
-------
Type of Fumigation and
Storage
Recommended Dosage (In Terms of Product)
Pellets a (55-60% P/T)
Tablets b (55-60% P/T)
Bags c (55-57% D)
(55-60% P/T)
(60% Impr)
Sachets c (57%
Impr)
200-450 pellets/1,000
bushels
Tanks
or
150-450 pellets/1,000 cu.
ft.
40-90 tablets/1,000
bushels
or
30-90 tablets/1,000 cu. ft.
2-8 bags/1,000
bushels
or
4-6 sachets/1,000 cu.
ft.
2-7 bags/1,000 cu. ft.
250-900 pellets/1,000
bushels
Flat storage
or
250-900 pellets/1,000 cu.
ft.
50-180 tablets/1,000
bushels
or
50-180 tablets/1,000 cu.
ft.
2-16 bags/1,000
bushels
or
2-13 bags/1,000 cu.
ft.
5-13 sachets/1,000 cu.
ft.
Farm bins (including Butler
type of bins which are well
constructed and reasonably gas
tight)
200-900 pellets/1,000
bushels
or
350-900 pellets/1,000 cu.
ft.
90-180 tablets/1,000
bushels
or
70-180 tablets/1,000 cu.
ft.
2-16 bags/1,000
bushels
or
2-13 bags/1,000 cu.
ft.
6-13 sachets/1,000 cu.
ft.
Loosely piled commodity
stored under temporary,
relatively gas-tight covering
270-540 pellets/1,000
bushels
90-180 tablets/1,000
bushels
45
(continued; footnotes follow)
-------
Type of Fumigation and
Storage
Recommended Dosage (In Terms of Product)
Pellets a (55-60% P/T)
Tablets b (55-60% P/T)
Bags c (55-57% D)
(55-60% P/T)
(60% Impr)
Sachets c (57%
Impr)
200-450 pellets/1,000
bushels
Railcars
or
150-500 pellets/1,000 cu.
ft.
40-90 tablets/1,000
bushels
or
30-145 tablets/1,000 cu.
ft.
2-7 bags/1,000
bushels
2-6 bags/1,000 cu. ft.
3-6 sachets/1,000 cu.
ft.
Bunkers and tarped ground
storage
200-500 pellets/1,000
bushels
or
150-500 pellets/1,000 cu.
ft.
40-100 tablets/1,000
bushels
or
30-100 tablets/1,000 cu.
ft.
2-8 bags/1,000
bushels
2-6 bags/1,000 cu. ft.
3-6 sachets/1,000 cu.
ft.
200-900 pellets/1,000
bushels
Barges
or
150-725 pellets/1,000 cu.
ft.
40-180 tablets/1,000
bushels
or
30-145 tablets/1,000 cu.
ft.
2-9 bags/1,000
bushels
or
3-7 sachets/1,000 cu.
ft.
2-7 bags/1,000 cu. ft.
200-413 pellets/1,000
bushels
Shipholds
or
100-375 pellets/1,000 cu.
ft.
40-83 tablets/1,000
bushels
or
30-75 tablets/1,000 cu. ft.
2-7 bags/1,000
bushels
or
3-6 sachets/1,000 cu.
ft.
2-6 bags/1,000 cu. ft.
Stored beehives, supers, and
other beekeeping equipment for
wax moth control and
Africanized honeybees infested
with tracheal mites and
foulbrood.
150-225 pellets/1,000 cu.
ft.
30-45 tablets/1,000 cu. ft.
3-4 bags/1,000 cu. ft.
46
(continued; footnotes follow)
-------
Type of Fumigation and
Storage
Small containers (i.e., spices)
Recommended Dosage (In Terms of Product)
Pellets a (55-60% P/T)
1 -2 pellets/1. 4- 10 cu. ft.
Tablets b (55-60% P/T)
1 tablet/6.9-50 cu. ft.
Bags c (55-57% D)
(55-60% P/T)
(60% Impr)
1 bag/6.9-500 cu. ft.
Sachets c (57%
Impr)
—
Miscellaneous
Non-food products
Outdoor fumigation of rodent
burrows (agricultural and non-
cropland areas)
150-450 pellets/1,000 cu.
ft.
5-20 pellets/burrow
30-90 tablets/1,000 cu. ft.
1-4 tablets/burrow
—
2-6 bags/burrow
—
—
Each pellet weighs -0.6 g and releases -0.2 g of phosphine.
Each tablet weighs ~3 g and releases ~ 1 g of phosphine.
The bags and sachets each weigh -34 g and release ~ 11 g of phosphine.
47
(continued; footnotes follow)
-------
Table 10. Recommended Dosage Rates For Magnesium Phosphide By Type of Fumigation and Storage.
Type of Fumigation and
Storage
Recommended Dosage (In Terms of Product)
Pellets a (66% P/T)
Tablets b (66% P/T)
Bags c (66% P/T)
FUMI-CEL Plate d
(56% Impr)
Space
Mills and warehouses
Bagged commodities
Processed fruits and nuts
Stored tobacco
Processing machinery and
equipment (spot fumigation)
100-300 pellets/1,000 cu.
ft.
150-300 pellets/1,000 cu.
ft.
100-200 pellets/1,000 cu.
ft.
100-200 pellets/1,000 cu.
ft.
25-50 pellets/1,000 cu. ft.
20-60 tablets/1, 000 cu. ft.
30-60 tablets/1,000 cu. ft.
20-40 tablets/1, 000 cu. ft.
20-40 tablets/1, 000 cu. ft.
—
2-6 bags/1, 000 cu. ft.
2-6 bags/1, 000 cu. ft.
2-6 bags/1, 000 cu. ft.
2-6 bags/1, 000 cu. ft.
—
1 plate/550-1,650 cu.
ft.
1 plate/550-1, 100 cu.
ft.
1 plate/825-1,650 cu.
ft.
1 plate/825-1,650 cu.
ft.
—
Bulk Stored Commodities
Vertical storage
Tanks
Flat storage
Farm bins
Bunkers and tarped ground
storage
Railcars
150-375 pellets/1,000 cu.
ft.
150-450 pellets/1,000 cu.
ft.
250-900 pellets/1,000 cu.
ft.
350-900 pellets/1,000 cu.
ft.
150-500 pellets/1,000 cu.
ft.
150-400 pellets/1,000 cu.
ft.
30-75 tablets/1,000 cu. ft.
30-90 tablets/1,000 cu. ft.
50- 180 tablets/1, 000 cu.
ft.
70- 180 tablets/1, 000 cu.
ft.
30-100 tablets/1,000 cu.
ft.
30-80 tablets/1,000 cu. ft.
2-6 bags/1, 000 cu. ft.
2-6 bags/1, 000 cu. ft.
2-6 bags/1, 000 cu. ft.
2-6 bags/1, 000 cu. ft.
2-6 bags/1, 000 cu. ft.
2-6 bags/1, 000 cu. ft.
1 plate/550-1, 100 cu.
ft.
1 plate/470- 1,1 00 cu.
ft.
1 plate/230-660 cu. ft.
1 plate/230-470 cu. ft.
1 plate/4 10- 1,1 00 cu.
ft.
1 plate/5 10- 1,1 00 cu.
ft.
48
(continued; footnotes follow)
-------
Type of Fumigation and
Storage
Barges
Shipholds
Small sealable enclosures
Stored beehives, supers, and
other beekeeping equipment
Recommended Dosage (In Terms of Product)
Pellets a (66% P/T)
150-500 pellets/1,000 cu.
ft.
150-375 pellets/1,000 cu.
ft.
1 pellet/1. 4- lOcu. ft.
150-225 pellets/1,000 cu.
ft.
Tablets b (66% P/T)
30-100 tablets/1,000 cu.
ft.
30-75 tablets/1,000 cu. ft.
1 tablet/6.9-50 cu. ft.
30-45 tablets/1,000 cu. ft.
Bags c (66% P/T)
2-6 bags/1, 000 cu. ft.
2-6 bags/1, 000 cu. ft.
1 bag/6.9-50 cu. ft.
3 bags/1,000 cu. ft.
FUMI-CEL Plate d
(56% Impr)
1 plate/230-660 cu. ft.
1 plate/500-1 100 cu.
ft.
—
—
Miscellaneous
Outdoor fumigation of rodent
burrows (agricultural and non-
cropland areas)
5-20 pellets/burrow
opening
1-4 tablets/burrow
opening
2-6 bags/burrow
opening
—
Each pellet weighs -0.6 g and releases -0.2 g of phosphine.
Each tablet weighs ~3 g and releases ~ 1 g of phosphine.
Each bag weighs -34 g and releases ~ 11 g of phosphine.
A FUMI-CEL Plate releases 33 g of phosphine.
49
(continued; footnotes follow)
-------
GLN 860.1300 (171-4 a.bV Nature of the Residue - Plants and Animals
No additional plant and animal metabolism data are required for
purposes of reregi strati on. The residue of concern is phosphine and the
current tolerance expression is appropriate. The original Registration
Standards for aluminum and magnesium phosphide reserved the requirements
for human health studies until certain uncharacterized residues which resulted
from the treatment of food were characterized and evaluated. Subsequent to
the issuance of the Registration Standards, the Agency received information
which identified these formerly unknown residues as oxidation products of
phosphine. Having reviewed these data, the Agency has concluded that these
decomposition products of phosphine are lexicologically insignificant at the
levels found in the treated commodities. Therefore, the Agency waived the
requirements for metabolism, residue, and storage stability data.
GLN 860.1340 (171-4 c.dV Residue Analytical Methods
The reregi strati on requirements for residue analytical methods are
fulfilled. 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 (LOD
= 0.01 ppm) and a GLC method with flame photometric detection (LOD =
0.001 ppm) as Methods A and B, respectively, for the enforcement of
tolerances. Both methods determine the level of phosphine residues. It is
noted that Method A remains a lettered method because of variable recoveries
observed in an Agency method try-out. However, the method has been
determined to be acceptable for enforcement because phosphine is highly
reactive, and finite residues are not expected. Data submitted in support of
the established tolerances were collected by one of these two methods.
GLN 860.1360 (171-4 in): Multiresidue Methods
Because aluminum and magnesium phosphide are inorganic
compounds, recovery of residues using FDA Multiresidue Protocols is not
expected, and the requirement for such data is waived.
GLN 860.1380 (171-4 eV Storage Stability Data
No additional storage stability data are required for the purposes of
reregistration. The Agency waived the requirements for this guideline.
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GLN 860.1400 (171-4 f.g.hV Water. Fish, and Irrigated Crops
Aluminum and magnesium phosphide are presently not registered for
direct use on potable water or aquatic food and feed crops; therefore, no
residue chemistry data are required under this guideline.
GLN 860.1460 (171-4 D: Food-Handling
No additional data pertaining to magnitude of the residue in food-
handling establishments are required for the purposes of reregistration.
GLN 860.1480 (171-41V Meat. Milk. Poultry, and Eggs
The reregistration requirements for data on magnitude of the residue
in animals are waived. There is no reasonable expectation of secondary
residues of phosphine in meat, milk, poultry, or eggs [Category 3 of 40 CFR
§180.6(a)] based on the registered uses.
GLN 860.1500 (171-4 kV Crop Field Trials
No additional data pertaining to magnitude of the residue are required
for purposes of reregistration because there are no uses of this type.
Residue data reflecting registered postharvest treatments of stored raw
agricultural and processed commodities indicate that, with adequate aeration
or further processing after treatment, residues of phosphine dissipate to
nondetectable levels. Residue data also suggest that the phosphine released
from registered aluminum and magnesium phosphide products are not
significantly different. Since aluminum and magnesium phosphide have
essentially identical use patterns, the available residue data for aluminum
phosphide may be translated to magnesium phosphide. Existing tolerances
reflect a 48-hour aeration period. No additional data are required to support
the registered uses of aluminum and magnesium phosphide on animal burrows
or den entrances for the control of rodents and moles.
GLN 860.1520 (171-4 D: Processed Food/Feed
No additional processing data are required for purposes of
reregistration.
GLN 860.1850 (165-n and 860.1900 (165-2V Confined/Field Accumulation
in Rotational Crops
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Data pertaining to confined/field accumulation in rotational crops are
not required for the purposes of reregi strati on.
b. Dietary Exposure from Drinking Water
Aluminum and magnesium phosphide are expected to degrade rapidly
in the environment to aluminum hydroxide and magnesium hydroxide and
phosphine. The Agency has determined that phosphine gas will degrade in
days and has a low exposure potential for contaminating ground and surface
water. Therefore, the Agency concludes that a dietary exposure assessment
from drinking water is not necessary.
The Agency determined that the use of standard models to estimate
concentrations of phosphine in surface and ground water are not appropriate
for this compound because: the compound is highly volatile and volatilization
is not considered as a route of dissipation in the models; the outdoor/field use
pattern (i.e. placing aluminum and magnesium phosphide in burrows) does not
present a surface water concern because the compound is not applied to the
soil surface and would not be expected to runoff in surface water; uses will be
localized since the only outdoor application is to rodent burrows; and only a
small percent of total use is outdoors.
While it is conceivable that some proportion of phosphine could reach
ground water through macropore flow-like processes, the Agency could not
estimate with any degree of certainty the concentration that would occur in
groundwater, and does not believe it would be a concern, due to the low
potential for exposure and the fate characteristics noted above.
c. Occupational and Residential Exposure
An occupational and/or residential exposure assessment is required for
an active ingredient if 1) certain toxicological criteria are triggered; and 2)
there is potential exposure to handlers (mixer/loaders, applicators, etc.) during
use or to persons entering treated sites after application is complete. Use of
aluminum and magnesium phosphide triggers both of the above requirements
and thus an exposure assessment is warranted.
(1) Application Practices
The application practices, methods and rates are discussed in the use
profile presented on pages 2-6 above. Please refer to that section for a
complete discussion.
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(2) Handler Concerns/Requirements/Restrictions
The primary handler concern from aluminum and magnesium
phosphide fumigation is acute inhalation exposure. Although manufacturers
of aluminum/magnesium phosphide indicate a delay before dangerous amounts
of phosphine are released (usually between 30 and 90 minutes), this time may
be significantly decreased if the chemical is handled under warm, humid
conditions (Leesch et al., 1995). ANational Institute of Occupational Safety
and Health (NIOSH) review of grain fumigation with phosphide stated
"...substantial exposures to phosphine can and do occur as soon as the original
containers of aluminum phosphide are opened" (NIOSH, Zaebst, A., et. al.
1987). Additionally, when released too quickly in a confined area, fire and/or
explosions may occur. Under the Agency's "Label Improvement for
Fumigants," changes have been made to better define user information and
precautionary statements. Revised labels state that at least two trained
persons must be present during the principle fumigation. These fumigators
should be licensed and present during application and aeration of a structure.
Detectors are required to monitor fumigant concentrations as a condition of
reentry or transfer of treated grain.
According to the current labels, exposure to phosphine must not
exceed an 8 hour time-weighted average (TWA) of 0.3 ppm (0.0004 mg/1) for
applicators and workers during application. This standard (0.3 ppm) was
developed as the permissible exposure limit (PEL) by the Occupational Safety
and Health Administration (OSHA). It should be noted that this value does
not take into consideration the potential for chronic phosphorus poisoning
from prolonged exposure (ACGIH Publication 0206). Application is defined
as the time period covering the opening of the first container, applying the
appropriate first dosage of fumigant and closing up the site to be fumigated.
All persons in the treated site and in adjacent indoor areas are covered by this
exposure standard. After application is completed, worker or applicator
exposure must not exceed a 0.3 ppm maximum concentration. A
NIOSH/MSHA approved full face gas mask/hydrogen phosphide canister
combination must be used at concentrations up to 15 ppm. Above this level,
or if the concentration is unknown a NIOSH/MSHA approved self-contained
breathing apparatus (SCBA) or equivalent must be available at the application
site. According to current labels, placarding should not be removed until the
treated commodity is aerated down to 0.3 ppm or less.
Since current labels often refer to OSHA standards a brief overview
of some OSHA requirements that may be related to the use of aluminum and
magnesium phosphide is presented here. The Occupational Safety and Health
Act requires employers to establish and maintain a safe and healthy work
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place. Therefore OSHA limits the exposure of workers to hazardous
chemicals, such as hydrogen phosphide gas. The principal of the 'action
level,' which is usually set at half the PEL, is to set a level of hazard that
serves as a warning and initiates measures to prevent that hazard from
exceeding the PEL. The PEL, in turn is the amount of hazardous substance
to which it is believed an average worker may be exposed for eight hours a
day, five days a week, for forty years. This regulatory limit assumes that not
all workers will be protected by this limit, particularly if they have a pre-
existing health condition. Therefore the PEL is not designed or intended to
protect bystanders or the public, who may be exposed to an airborne chemical
up to 24 hours a day if such a chemical is released into the community air.
Nor is the PEL adequately protective of infants, the elderly, sensitive
individuals, or the infirm.
The revised PPE Standard was promulgated by OSHA in 1994 and
requires employers to evaluate the hazards present or potentially existing in
the work place. Based on this assessment, employers must provide all
appropriate personal protective equipment to employees to permit them to do
their jobs safely. If respirators are required to perform a job, then the
employer must have a respiratory protection plan. The plan requires medical
clearance, training, fit testing, and proper respirator selection. Employees
working with phosphine will need to be trained to monitor the levels of
phosphine gas and select a respirator with an appropriate protection factor.
Employees will then be expected to clean and maintain their respirator and
change chemical cartridges when they are depleted.
Definitions of several OSHA terms used in this document are:
PEL: Permissible Exposure Limit: the amount of chemical permitted to be in
the atmosphere of the work environment, based on a time-weighted average
[TWA] concentration measured for an eight-hour day. The limits are listed
in the 29 CFR 1910.1001 table z-1.
AL: Action Level: The level of contaminant in the work atmosphere at which
administrative (e.g. worker rotation, limiting exposure), engineering (e.g.
exhaust ventilation, contaminant isolation), or personal protection controls
must be implemented. Generally equal to one-half the PEL.
Ceiling Value: A level of contaminant in the work atmosphere which may not
be exceeded at any time.
STEL: Short Term Exposure Limit (is supplemental to the PEL or TLV's 8-
hr TWA): The level of contaminant in the work atmosphere to which an
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average worker may be exposed for 15 minutes without significant health
effects. A maximum of four 15-minute periods per eight hour shift, 60
minutes in between each 15 minute exposure, is allowable, as long as the
worker does not exceed the daily 8-hr-TWA.
TWA: Time-Weighted Average: The worker's personal cumulative exposure
for one shift divided by eight hours.
(3) Handler Exposures and Assumptions
The estimates of exposure in this assessment have been derived from
a phosphine chemical specific studyconducted by S.Z. Mansdorf et al. entitled
"Phosphine Exposure Monitoring for Applicators, Workers, and Nearby
Persons" (MRID 40717201). The Mansdorf et. al. study monitored exposure
to fumigators (and helpers); bystanders during and post-fumigation (but
before aeration); aerators; and bystanders during and post-aeration.
Occupational bystanders/nearby persons have been defined by Mansdorf et.
al. as someone with "no direct contact with the fumigant material and/or
container during or anytime after fumigation and no direct or indirect contact
with spent fumigant container after aeration". The fumigants were applied to
concrete upright bins, bulk railcars, railroad box cars, processing plants,
tobacco warehouses, farm bins, flat bins, and in spot fumigation situations.
Each site had workers in short term (1 to 7 days) and intermediate term (1
week to several months) exposure situations, and many of the sites had
chronic situations (5 days/week for 6 months) as well. Note that although
some fumigations seem only short-term in nature, the potential for
intermediate exposure exists for the commercial applicator. The materials and
methods are described in detail below. It should also be noted that this study
did not review all possible exposure scenarios that could result from the use
of aluminum and magnesium phosphide.
Concrete Upright Bins
Commodity fumigations in concrete upright bins were analyzed at
three sites. The first site was a large grain elevator and mill consisting of many
cylindrical and rectangular concrete upright bins. The cylindrical bins were
connected by interstitial (star-shaped) bins. This facility received and stored
several grades of grain. Fumigations occur daily due to the constant
movement of grain. Fumigation occurred through the use of automatic
dispensers. An applicator would add pellets to the dispenser which in turn
added the pellets to the grain at measured intervals. The second site was a
mid-size grain elevator and storage bin consisting of more than 40 cylindrical
concrete bins. As with the first site, the cylindrical bins were connected by
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interstitial bins. Fumigations were much less frequent than at the first site,
averaging only 6 per year. Applicators manually added pellets to the grain as
it was transferred through the hatch at approximately 100 pellets every 7.5
minutes. The third site was a large grain elevator and storage bin complex
consisting of both concrete and flat storage bins. The high volume of grain
demanded almost daily fumigation. As with the first site, pellets were added
to grain through the use of automatic dispensers.
The duration of exposure from concrete upright fumigation was
greater than any other site or complex in the study. Daily fumigant
applications could take up to 12 hours depending on the size of the bin being
filled. Unlike other facilities where phosphine exposure may be brief (due to
rapid fumigation), the study noted that residue concentrations from concrete
upright fumigation were probably consistent throughout the day. The daily
fumigations/aerations over a 6-8 month season constitutes chronic exposure.
Bulk Railcars and Railroad Boxcars
Four sites examined worker exposure from the fumigation and
aeration of bulk railcars and railroad boxcars at large grain elevators, mills, or
cereal processing plants. Single car fumigation or aerations usually lasted
under 45 minutes; however, the number of cars treated at facilities varied. For
example, at one site the fumigation of outgoing railcars took up to 3.5 hours
per day. The average appeared to be an applicator treating between 2 and 4
cars/day over a 6 to 8 month "season". This constitutes a chronic use pattern.
These findings and potential chronic use patterns were similar to those in
another study (Shaheen, Donald G. Letter to Jeff Kempter of Registration
Division, 2/20/87). In this study, a survey of processing plants indicated that
up to 6-8 phosphine treated railcars/day could be unloaded at breweries, 0 -
1 treated railcars/day unloaded at mills, 3 treated railcars/day unloaded at feed
plants, and 1 treated car/day unloaded at cereal plants. Others from industry
felt that while the potential for chronic exposure existed, fewer railcars or
bulkcars would be treated or aerated than seen by Shaheen or in the Mansdorf
et al. study. (Hegele, Fred. General Mills. Personal Communication, January
1998.; Sawyer, Glenn. Industrial Fumigants. Personal Communication,
January, 1998). Blister pacs (prepac strips) or dust sachets were placed on
cardboard discs in the cars and the hatches were sealed. Aerations occurred
either in the large indoor rail docks used for fumigation or outside in the
switching yard. Fumigations usually involved one applicator or an applicator
and assistant. Aerations involved 1 or 2 workers.
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Spot fumigation
Spot fumigation occurred at one of the mid-size grain elevators and
mill complexes. At this facility mill, equipment was fumigated every third
weekend and took approximately one hour. Aeration and retrieval of unused
chemical took approximately 1.5 hours, and took place 36 hours after
fumigation.
Tobacco Warehouses
The facility examined in the Mansdorf et al. study used prepac blister
strips. Each warehouse was sealed with polyethylene sheeting prior to
fumigation. The fumigation crew of 8 to 10 applicators started at the front
end of the warehouse, opened the pouches and placed the pesticide strips in
a zig-zag pattern on metal trays and worked their way towards the exit. The
exit was a slit in the plastic sheeting and was sealed after all the crew had
exited.
The tobacco warehouse in the Mansdorf et al. study represented ideal
fumigation and aeration practices and the resulting data should be considered
a "best case scenario" (EPA memo dated 1992). Actual data from other
facilities could potentially show greater exposure. Shaheen found off-gassing
problems most notably in tobacco warehouses where the combination of
hogsheads of tobacco and tobacco packaging of polyethylene sheeting result
in the retention of phosphine for periods considerably longer than the 72-hour
aeration.
Farm and Flat Storage Bins
Many of the sites analyzed were farm and flat storage bins from a
series of farms and small town storage facilities. The farm bins were usually
made of bolted steel and were cylindrical in shape with conical roofs. The
small town sites had facilities with welded steel cylindrical tanks or large
rectangular structures. These are called "flat storage bins". They have a
larger storage capacity than the farm bins. These fumigations were conducted
by a professional fumigation company. Workers from the team reported
approximately 20 fumigations per year. The methods of application varied
from shaking the fumigant material onto the surface of a commodity, to
submerging a flask 2-3 inches below the commodity surface, to using a probe
(pipe) to pour the fumigant into the center of the commodity. The most
common method of application in these sites was shaking the fumigant
material onto the surface of the commodity without tarping or powered
aeration.
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Commodity Transfers
At three sites, samples were collected on "post-aeration" workers at
a finished product packaging line and while transferring fumigated grain to
bulk railcars. The reduced replicate number and conflicting use information
in this study has in part determined how exposure and risk was estimated (as
discussed later in this assessment). Despite these deficiencies, the Agency has
determined that this study represents the best available data for assessing
exposure to aluminum and magnesium phosphide.
The residue of phosphine gas per liter of air drawn through the
sampling media was calculated with the following formula:
Residue (mg/1) = (As + t x f) + 1000
where:
As = amount of phosphine collected on the sample tube in micrograms
t = sample time in minutes
f = average pump flow rate in liters of air per minute
Table 11 summarizes the mean concentration and concentration range
for each specific facility and handler function. Data from different sites for the
same function and facility (e.g. bulk railcar fumigations) were pooled in order
to maximize the number of replicates for each function.
(4) Animal Burrow Treatment
A study entitled Exposure of Persons to Phosphine Gas from
Aluminum Phosphide Application to Rodent Burrows was conducted by Rex
O. Baker, Professor at California State Polytechnic University in 1992.
Worker exposure was assessed for two methods of applying aluminum
phosphide tablets to rodent burrows: hand and mechanical application. At the
end of the workday, phosphine levels on gloves, shirts, and pants were
measured by sealing each garment in a plastic bag with approximately 1.5
cubic feet of air. The air concentration within the bags was measured with
direct reading detector tubes after approximately 30 minutes. The mechanical
applicators were found to have less residue than the hand applicators on the
shirts (0.07 ppm and 0.29 ppm, respectively), pants (0.167 ppm and 0.875
ppm, respectively), and gloves (0.59 ppm and 2.11 ppm, respectively).
Measurements, using the procedure above, were taken on the same garments
the next morning, prior to the start of work, to determine whether overnight
aeration is a sufficient method of cleaning the work clothes. One shirt out of
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56 was found to have residual levels of phosphine after overnight aeration.
In addition, two pairs of pants and six pairs of gloves were found to have
residual levels of phosphine, however, these levels occurred in weather that
was near freezing (24° to 48° F). The gloves used in this study were made of
smooth leather; during the initial stages of the study, it was found that
phosphine gas dissipated from leather gloves much more readily (after
approximately 4 hours) than from cotton gloves (approximately 20 hours).
Air concentrations in the breathing zone were measured with
monitoring badges clipped to the collars of the workers' shirts. These badges
were worn for the entire workday (i.e., 8-hours), and the exposures were
calculated on a time-weighted-average (TWA) basis. Four of the 21
measurements for hand applicators had detectable levels of phosphine gas.
The total exposures ranged from 0.1 ppm to 0.8 ppm, which equate to TWAs
of 0.012 ppm to 0.1 ppm. None of the 21 measurements for mechanical
applicators had detectable levels of phosphine gas.
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Table 11. Summary Table of Inhalation concentrations
Site J| Scenario
Concrete upright facility
Bulk railcar
Railroad Boxcar
Tobacco Warehouse
Flat Bin
Farm Bin
Fumigation
Fumigation
Post fumigation, before aeration
Post aeration
Fumigation
Fumigation
Post fumigation, before aeration
Aeration
Post aeration
Fumigation
Fumigation
Fumigation, during and post
Post fumigation, before aeration
Aeration
Post aeration
Fumigation
Aeration
Post aeration
Fumigation
Fumigation
Activity
Fumigator
Bystander
Bystander
Bystander
Fumigator
Bystander
Bystander
Aerator
Bystander
Fumigator
Bystander
Bystander
Bystander
Aerator
Bystander
Fumigator
Aerator
Bystander
Fumigator
Fumigator
Mean Concentration (mg/1)
1.4x10-4
1.1x10-4
9.9x10-5
5.4x10-5
3.9x10-4
2.3 x 10-4
8.7x10-5
9.4 x 10-4
1.2x10-4
3.6x10-4
2.5 x 10-4
2.0 x 10-4
2.3 x 10-4
6.3 x 10-4
6.2 x 10-4
2.8x10-4
1.3x10-4
5.8x10-5
7.3x10-3
1.2x10-3
Concentration Range (nig/1)
4.4 x 10-6 to 6.3 x 10-4
2.7x10-6 to 8. 5x10-4
3.2x10-6 to 3. 1x10-4
1.9x10-5 to 1.4x10-4
4.3 x 10-5 to 9.4 x 10-4
1.1x10-4 to 7.1x10-4
8. 1x10-5 to 9. 8x10-5
4. 8x10-4 to 1.6x10-3
7. 1x10-5 to 2. 1x10-4
3. 5x10-5 to 1.4x10-3
1.2x10-5 to 4. 3x10-4
4.0 x 10-5 to 6.3 x 10-4
9. 7x10-6 to 9. 1x10-4
1.2x10-4 to 1.3x10-3
6.2 x 10-4 (1 replicate)
9.5 x 10-5 to 7.2 x 10-4
3.4x10-5 to 2. 1x10-4
3.2x10-5 to 9.7x10-5
3. 9x10-5 to 2. 5x10-2
4. 9x10-4 to 4. 1x10-3
60
(continued; footnotes follow)
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Site J| Scenario
Spot Fumigation
Commodity transfer-packaging plant
Commodity transfer-grain transfer
Fumigation
Aeration
Post aeration
Post aeration
Activity
Fumigator
Aerator
Bystander
Bystander
Mean Concentration (mg/1)
4.3x10-3
8.7x10-5
1.7x10-4
4.5x10-5
Concentration Range (mg/1)
3.8x10-3 to 4.9x10-3
7.8 x 10-5 to 9.6 x 10-5
1.9x10-5 to 1.2x10-3
1.9x10-5 to 7.0x10-5
61
(continued; footnotes follow)
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4. Risk Assessment
There is potential for both dietary (food) and occupational exposure from the
use of aluminum and magnesium phosphide. As previously noted, dietary exposure
from drinking water is not expected. There is a limited registered residential use at
the present time. However, the Agency has proposed that this use be removed.
Further, the Agency is concerned about the risk to residential bystanders which is
included as part of the occupational risk assessment. Dietary exposure occurs via the
oral route, while occupational exposure occurs via the inhalation route. Dietary
exposure is expected to be short-term (acute) and long term (chronic), while
occupational exposure is expected to be short-term, intermediate term and long-term.
To assess the acute and chronic dietary risk, the Agency calculated the percent of the
reference dose [RfD] (i.e. % RfD) used by the registered uses. To calculate
occupational risk, the Agency calculated a Margin of Exposure (MOE).
In examining aggregate exposure, FQPA requires that EPA consider available
information concerning exposure from the pesticide residue in food and all other
exposure for which there is reliable information. These other sources of exposure of
the general population (including infants and children) to pesticides include residues
in drinking water and non-occupational exposures to pesticides. Only food source
exposure was evaluated. Drinking water exposure is not expected. There is a limited
registered residential use at the present time. However, the Agency has proposed that
this use be removed.
a. Dietary Risk Assessment
Dietary exposure to aluminum and magnesium phosphide can
potentially occur via residues of phosphine gas remaining in treated
commodities. For all data submitted to the Agency for establishment of food
tolerances, residues of phosphine gas have been typically reported as non-
detectable. However, because the use of aluminum and magnesium phosphide
is considered a food use, tolerances for phosphine gas are required. The
tolerances are intended for enforcement purposes, i.e., to monitor and
safeguard against misuse, not for risk assessment. The tolerances are
established based on the limits of quantification of the analytical method for
phosphine gas. Anticipated residues were used for the both the chronic and
acute dietary exposure analyses.
Section 408(b)(2)(D) of the FQPA established factors that the Agency
must consider in determining whether the safety standard is met in deciding
to issue or reassess tolerances. These factors include the consideration of
available information on aggregate exposures to the pesticide from dietary
sources, including drinking water, as well as non-occupational exposures,
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such as these derived from pesticide uses in and around the home. The
Agency must also consider the potential cumulative effects of the pesticide for
which a tolerance is being sought as well as other substances that have a
common mechanism of toxicity.
In examining aggregate exposure, FQPA directs the Agency to take
into account available information concerning exposures from pesticide
residues in food and other exposures for which there is reliable information.
These other exposures may include drinking water and non-occupational
exposure, such as from pesticides used in and around the home.
In the case of aluminum and magnesium phosphide, only food source
exposure contributes to the aggregate risk posed by these pesticides.
Drinking water exposure is not expected. There is a limited registered
residential use at the present time. However, the Agency has proposed that
this use be removed. Although accidental exposure to bystanders is a concern
which will be examined in the occupational exposure section of this document,
it does not constitute an exposure scenario that is typical of the proper use of
the pesticides and thus is not included as part of the aggregate assessment.
i. Acute Dietary (Food Source) Risk
Estimates of acute dietary exposure were conducted using
DEEM™ analysis. The acute DEEM™ analysis evaluates the
individual food consumption as reported by respondents in the USDA
1989-1991 nationwide Continuing Surveys for Food Intake by
Individuals (CSFII), and accumulates exposure to the chemical for
each commodity. In order to conduct a conservative dietary exposure
analysis, anticipated residues equal to the highest limit of detection
(0.006 ppm) are being used for acute dietary exposure analysis.
Additionally the conservative assumption was made that 100% of all
commodities included in the DEEM™ data base (except
meat/milk/poultry/eggs) would contain residues at that anticipated
residue level.
The results of the DEEM™ acute dietary (food) exposure
analysis for exposure at the 99.9th percentile in terms of percents of
the acute RfD ranged from 22% (U.S. population) to 27% (non-
nursing infants). Acute dietary (food) exposure does not exceed the
Agency's level of concern. The percent of the acute RfD occupied,
at the 99.9th percentile, is less than 30% for the population subgroups
examined.
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These estimates of acute dietary exposure are partially refined,
yet still conservative in that was assumed that all food (except
meat/milk/poultry/eggs) consumed by an individual would contain
phosphine gas residues at 0.006 ppm. This anticipated residue level
is based on the highest limit of detection reported in tolerance
petitions. The Agency notes that all tolerances are based upon non-
detectable residues in residue field trials. Because phosphine gas will
dissipate into the atmosphere, especially as foods are cooked (heated)
or prepared, residues are unlikely to be found on food at the time of
consumption.
ii. Acute Dietary (Drinking Water) Risk
The Agency has considered the registered uses and the
available data on the persistence and mobility of aluminum and
magnesium phosphide. The Agency has determined through a
qualitative risk assessment that the use patterns associated with
aluminum and magnesium phosphide are not expected to impact water
resources through labeled uses. In light of this finding, the Agency
believes that aluminum and magnesium phosphide use will not impact
groundwater or surface water resources, and therefore, is not
expected to lead to exposure to humans through drinking water. If
new uses are added in the future, the Agency will reassess the
potential impacts of aluminum and magnesium phosphide on drinking
water as part of the aggregate risk assessment process.
iii. Aggregate Acute Dietary (Food Source and Drinking Water)
Risk
As noted above, since an acute dietary (drinking water) risk
assessment is not required, aggregate acute dietary risk reflects food
source risk only. Thus, based on the acute dietary (food) risk
assessment, aggregate acute dietary risk does not represent a concern.
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iv. Chronic Non-Cancer Dietary (Food Sources) Risk
Estimates ofchronic dietary exposure were conducted using
DEEM™ analysis. The chronic DEEM™ analysis evaluates the
individual food consumption as reported by respondents in the USDA
1989-1991 nationwide Continuing Surveys for Food Intake by
Individuals (CSFII), and accumulates exposure to the chemical for
each commodity. In order to conduct a conservative dietary exposure
analysis, anticipated residues equal to the highest limit of detection
(0.006 ppm) are being used for acute dietary exposure analysis.
Additionally the conservative assumption was made that 100% of all
commodities included in the DEEM™ data base (except
meat/milk/poultry/eggs) would contain residues at that anticipated
residue level.
The formula to calculate the percent RfD is:.
% RfD = chronic dietary (food source) exposure (mg/kg/day)
RfD (mg/kg/day)
The results of the DEEM™ chronic analysis are presented in
the table below.
Table 12. Chronic Dietary Exposure and % RfD for the General U.S. Population and Sensitive
Subpopulations
Subgroup
General U.S. population
Non-nursing infants (< 1 year
old)
Children (1-6 years old)
Exposure (mg/kg/day)
2.6 x ID'4
l.Ox ID'3
4.7 x ID'4
% Reference Dose1
2%
9%
4%
Chronic RfD = 0.0113 mg/kg/day
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As represented in the table above, reassessed tolerance levels
residues on commodities result in exposures which are 2% of the
chronic RfD for the general U.S. population and 9% of the RfD for
non-nursing infants (< 1 year old). Chronic dietary (food) exposure
does not exceed the Agency's level of concern based on these %RfDs.
The percent of the chronic RfD occupied is less than or equal to 9%
for the population subgroups examined.
These estimates of chronic dietary exposure are partially
refined, yet still conservative in that was assumed that all food (except
meat/milk/poultry/eggs) consumed by an individual would contain
phosphine gas residues at 0.006 ppm. This anticipated residue level
is based on the highest limit of detection reported in tolerance
petitions. The Agency again notes that all tolerances are based upon
non-detectable residues in residue field trials. Because phosphine gas
will dissipate into the atmosphere, especially as foods are cooked
(heated) or prepared, residues are unlikely to be found on food at the
time of consumption.
v. Chronic Drinking Water Risk
The Agency has considered the registered uses and the
available data on persistence and mobility for aluminum and
magnesium phosphide. The Agency has determined through a
qualitative risk assessment that the use patterns associated with
aluminum and magnesium phosphide are not expected to impact water
resources through labeled uses. In light of this finding, the Agency
believes that aluminum and magnesium phosphide use will not impact
ground water or surface water resources, and therefore, is not
expected to lead to exposure to humans through drinking water. If
new uses are added in the future, the Agency will reassess the
potential impacts of aluminum and magnesium phosphide on drinking
water as part of the aggregate risk assessment process.
vi. Aggregate Chronic Dietary (Food Sources and Water) Risk
As noted above, since a chronic dietary (drinking water) risk
assessment is not required, aggregate chronic dietary risk reflects food
source risk only. Thus, based on the chronic dietary (food) risk
assessment, aggregate chronic dietary risk does not represent a
concern.
vii. Dietary (food source and water) Carcinogenic Risk
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The carcinogenic potential of aluminum/phosphide has not
been extensively evaluated by the Agency due to a lack of tumor data.
The results of a non-guideline 2 year rat feeding study (Ascension nos.
26937, 2693 and 6000), did not indicate a carcinogenic concern.
Thus, the Agency does not believe that aluminum and magnesium
phosphide suggest a carcinogenic concern. In addition, a combined
chronic/carcinogenicity rat inhalation toxicity study is due to the
Agency in November, 1998 to provide confirmatory data.
b. Cumulative Risk
The Agency has not yet made a final decision concerning the possible
common mechanism of toxicity and the potential for cumulative effects of
aluminum and magnesium phosphide and other compounds. Therefore, for the
purposes of the tolerance reassessments in this RED document, the Agency
has considered only the risks of aluminum and magnesium phosphide.
In deciding to continue to make reregi strati on determinations during
the early stages of FQPA implementation, the Agency recognizes that it will
be necessary to make decisions relating to FQPA before the implementation
process is complete. In making these early, case-by-case decisions, the
Agency does not intend to set broad precedents for the application of FQPA
to its regulatory determinations. Rather, these early decisions will be made
on a case-by-case basis, and will not bind the Agency as it proceeds with
further policy development and rulemaking that may be required.
If the Agency determines, as a result of this later implementation
process, that any of the determinations described in this RED are no longer
appropriate, the Agency will consider itself free to pursue whatever action
may be appropriate, including but not limited to, reconsideration of any
portion of this RED.
c. Effects to the Endocrine System
The Agency is required to develop a screening program to determine
whether certain substances (including all active ingredient pesticides and
inerts) "may have an effect in humans that is similar to an effect predicted by
a naturally occurring estrogen, or such other endocrine effect." The Agency
is currently working with interested stakeholders, including other government
agencies, public interest groups, industry and research scientists in developing
a screening and testing program and a priority setting scheme to implement
this program. Congress has allowed three years from the passage of FQPA
(deadline of August 3, 1999) to implement this program. At that time, the
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Agency may require further testing of these active ingredients and end use
products for endocrine disrupter effects.
d. Occupational and Residential Risk Assessment
The route of exposure of concern for occupational and residential
bystander risk is inhalation exposure. Because test data are available where
the route of exposure is inhalation, occupational risk was estimated by
calculating a route-specific MOE. A route-specific MOE is calculated by
dividing the NOEL for the route of exposure in the study by the human
exposure level for that same route of exposure. Since the units are the same
(mg/kg for oral and dermal; mg/L for inhalation), the units cancel to yield a
unitless MOE. The route specific MOE is preferred over a route-to-route
extrapolation because there is no need to estimate the percentage of test
particle absorption, or adjust for metabolism or any other pharmacokinetic
parameters. A route-specific inhalation MOE is calculated as follows:
NOEL (mg/L) x DA x AFA
MOE =
Human Airborne Concentration (mg/L) x Dfj x
DA Duration of daily animal exposure (usually 4 or 6 hours/exposure)
DH Duration of daily human exposure (hours/exposure)
AFA Activity Factor for animals (default is 1)
AFH Activity Factor for humans (accounts for activity-related variations in respiration)
The Science Advisory Panel and the Agency have endorsed the use of
route-specific MOEs whenever possible because they are accurate and easy
to combine with MOEs from other routes of exposure, even when the MOEs
have dissimilar uncertainty factors.
Table 13 represents a summary of the projected short, intermediate
and (where applicable) chronic MOEs for each facility and specific handler or
bystander/nearby persons for each hour increment up to 8 hours.
(Bystanders/nearby persons are not considered to have direct contact with the
fumigant material and/or container during or anytime after fumigation, or
direct or indirect contact with spent fumigant container after aeration). This
level of detail is provided because duration of worker exposure varies with the
site and handler function. The table represents MOEs for short term
(NOEL=5 ppm= 0.007 mg/L), intermediate term (NOEL=3 ppm=0.004
mg/L) and long term (chronic) (NOEL=3 ppm= 0.004 mg/L) exposure.
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The OSHA PEL for aluminum and magnesium phosphide is based on
a limited epidemiological study of grain fumigators by Jones et. al. (1962), and
corresponds to aNOEL of 0.3 ppm. While much of the Agency's analyses is
consistent with OSHA values, the Agency will regulate on NOELs of 0.03
and 0.05 ppm depending upon the length of exposure. These values are an
order of magnitude more protective than the OSHA PEL. The reason for this
difference is that the OSHA PEL is based upon a very limited epidemiological
study conducted in the early 1960's (Jones et. al.), while the Agency has
decided to use acceptable guideline studies conducted on animals together
with the accepted Uncertainty Factor. The Agency believes that this is a more
reliable and defensible basis for regulating the risks associated with these
pesticides.
For the purpose of short term risk assessment, the 8-hour MOE should
be used as a conservative risk estimate. Although most applications
apparently take less than one hour, some applications may take up to 12
hours. Bystanders may be exposed for beyond 12 hours depending on their
proximity to the structure. Additionally, some facilities had work days greater
than 8 hours (up to 12). Therefore, while conservative, the eight hours should
not be considered excessively conservative or unrealistic. MOEs have been
estimated at baseline (without PPE, as they are in the Mansdorf et al. study)
and with the addition of arithmetically estimated PPE. The protection
provided by a NIOSH/MSHA approved full face gas mask/hydrogen
phosphide canister combination was estimated at 98%. The protection
provided by a NIOSH/MSHA approved Self Contained Breathing Apparatus
(SCB A) operating in a negative pressure mode has been estimated at 99.99%.
MOEs for use of PPE by nearby persons (occupational bystanders) have also
been estimated.
Utilizing either the OSHA PEL or the Agency's endpoint for short-
term, intermediate-term, and long-term exposure, short-term MOEs were
greater than intermediate or chronic MOEs. MOEs were acceptable for all
exposure scenarios with use of PPE/SCBA during an 8-hour application
period. However, use of SCB A for an 8-hour application period would be
cumbersome.
The acceptability of the MOEs varied with each site, with no one
handler function being unacceptable throughout. Risk from phosphine
exposure seemed more of a function of the type of fumigation than the
specific handler function. Bulk railcar and railroad boxcar aerators had lower
MOEs than fumigators, whereas tobacco warehouse and spot fumigators had
lower MOEs than their aerator counterparts. Fumigators who performed spot
treatment or farm or flat bin fumigation had the lowest MOEs. In many cases,
69
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the full face respirator was not adequately protective when used for more than
1 or 2 hours and was never adequately protective for farm bin, flat bin and
spot fumigation. The use of SCBA raised MOEs to acceptable levels in all
scenarios.
Most significantly, occupational bystander exposure seems to be a
definite concern. Most handler scenarios had unacceptable occupational
bystander exposure at the baseline level (no handler scenario had acceptable
bystander MOEs for the full 8 hours, and most were not even acceptable at
1 or 2 hours). The use of PPE by a nearby worker could prove to be difficult,
especially if heavy physical labor is required. Of additional concern is
residential bystander exposure since PPE is not applicable to residential
bystanders. As previously discussed, poisoning data corroborate handler and
bystander risks, especially residential bystander risks.
Most of the estimated MOEs were greater when calculated with the
Mansdorf et al. study mean concentrations than with the OSHA PEL. This
is expected since the mean concentrations from the Mansdorf et. al. study
were mostly at or higher than the OSHA PEL. Notable exceptions to this
were farm and flat bin fumigation, spot fumigation, and bulk railcar aeration.
One of the limitations of the exposure study was the lack of replicates
for many of the exposure scenarios. Although it is useful to have information
on the many different handler and nearby functions, many scenarios had less
than 15 replicates, even with pooled data, and many had less than five. This
reduced replicate number makes it difficult to determine if the results are a
true estimate of exposure or are biased by the small replicate number. This
point becomes a critical issue when MOE estimates for some scenarios prove
unacceptable. Although, as Mansdorf et. al. point out, the residues in the
study do not reflect the protection afforded the worker by "the proper
respiratory protection," in many cases, no protection was worn by the worker.
The study provides some information regarding actual practices by
workers. At many of the sites analyzed, fumigators merely opened packaging
near an open door or window before application, with cotton gloves as the
only other discernible protection worn. Use of respiratory protection with flat
bin, farm bin, railroad box or bulk car fumigation was inconsistent, particularly
with the bulk or box car fumigators, who did not appear to wear any
respiratory protection at all. Therefore, Mansdorf, et. al.'s conclusion that
workers will always be exposed to lower concentrations (from wearing the
proper PPE) may not always be accurate if workers, in fact, wear the PPE.
Data from the Oklahoma Cooperative Extension Service also provides
information on actual practices. The Oklahoma Cooperative Extension
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Service concludes that only 36% of all grain elevator operators routinely use
SCBA and only 56% use canister respirators. Additionally, very few
operators were found to test for fumigant or oxygen levels, a legal
requirement. Only aerators and the spot fumigators consistently wore
respiratory protection of some kind.
Mansdorf et. al. additionally stated that, with the exception of concrete
upright facilities, sample times were representative of the concentration a
worker would be exposed to for an 8-hour day. This was not consistent
throughout the study, with some areas having at least an 8-hour day and often
only one fumigator and an assistant. Also, while the sample times
representing box or bulk car fumigations were accurate (where one sample
time equaled a single car fumigation and according to Mansdorf, a worker's
exposure for the day), the number of cars treated/day conflicted with data
provided by Shaheen which demonstrated that some facilities treat up to eight
cars in one day. This latter case corresponds to an approximate 5-hour
exposure/day.
The following tables summarize the results of the Mansdorf study.
The vast majority of MOEs for the baseline case are unacceptable. This is
significant because the baseline case represents the expected scenario for both
occupational and residential bystanders. A smaller but not insignificant
percentage of scenarios are unacceptable at the PPE/Full-Face Respirator.
These scenarios are: fumigators of railroad boxcars at 8 hours (short term);
aerators of railroad boxcars at 8 hours (short term); fumigators of flat bins at
1, 2, 4 and 8 hours (short term); fumigators of flat bins at 2, 4 and 8 hours
(intermediate term); fumigators of farm bins at 4 and 8 hours (short term);
spot fumigators at 2, 4 and 8 hours (short term); and spot fumigators at 4 and
8 hours (intermediate term), and bystanders during commodity transfer at 8
hours (short term).
71
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Table 13: Summary of Unacce
Duration of Exposure
1 hour
2 hour
4 hours
8 hours
TOTAL
(All scenarios/durations)
ptable MOEs for workers including bystanders
% Unacceptable MOEs
Baseline Case
64%
85%
98%
100%
87%
% Unacceptable MOEs
PPE Full-Face Respirator
Case
2%
6%
11%
19%
10%
Notes:
- Total # of scenarios equals 47
- In baseline case the assumption is that no respirator is worn
- Concentrations vary by scenario per Mansdorf et. al. study
72
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Table 14. Baseline MOEs for Workers and Bystanders
Scenario
Concrete upright facilities: Fumigators (ST)
Concrete upright facilities: Fumigators (IT/CT)
Concrete upright facilities: Bystanders during
Fumigation (ST)
Concrete upright facilities: Bystanders during
fumigation (IT/CT)
Concrete upright facilities: Bystanders after
fumigation (ST)
Concrete upright facilities: Bystanders after
fumigation (IT/CT)
Concrete upright facilities: Bystanders after
aeration (ST)
Concrete upright facilities: Bystanders after
aeration (IT/CT)
Bulk Railcar: Fumigators (ST)
Bulk Railcar: Fumigators (IT/CT)
Bulk Railcar: Bystanders during fumigation (ST)
Bulk Railcar: Bystanders during fumigation
(IT/CT)
Bulk Railcar: Bystanders after fumigation (ST)
Bulk Railcar: Bystanders after fumigation
(IT/CT)
Bulk Railcar: Aerators (ST)
1-Hour
30
140
22
180
62
200
140
370
20
51
27
87
190
230
12
2-Hour
15
71
11
91
31
100
68
190
10
26
13
43
97
110
6
4-Hour
8
36
6
45
15
51
34
93
5
13
7
22
49
57
3
8-Hour
4
18
3
23
8
25
17
46
3
6
3
11
24
29
2
73
(continued; footnotes follow)
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Scenario
Bulk Railcar: Aerators (IT/CT)
Bulk Railcar: Bystanders post aeration (ST)
Bulk Railcar: Bystanders post aeration (IT/CT)
Railroad Boxcars: Fumigators (ST)
Railroad Boxcars: Fumigators (IT/CT)
Railroad Boxcars: Bystanders during fumigation
(ST)
Railroad Boxcars: Bystanders during fumigation
(IT/CT)
Railroad Boxcars: Bystanders during and after
fumigation (ST)
Railroad Boxcars: Bystanders during and after
fumigation (IT/CT)
Railroad Boxcars: Bystanders after fumigation
(ST)
Railroad Boxcars: Bystanders after fumigation
(IT/CT)
Railroad Boxcars: Aerators (ST)
Railroad Boxcars: Aerators (IT/CT)
Railroad Boxcars: Bystanders post aeration (ST)
Railroad Boxcars: Bystanders post aeration
(IT/CT)
Tobacco Warehouse: Fumigators (ST)
1-Hour
21
91
170
14
56
44
80
30
100
21
87
15
32
31
32
27
2-Hour
11
45
83
7
28
22
40
15
50
10
43
7
16
15
16
13
4-Hour
5
23
42
3
14
11
20
8
25
5
22
4
8
8
8
7
8-Hour
3
11
21
2
7
6
10
4
13
3
11
2
4
4
4
3
74
(continued; footnotes follow)
-------
Scenario
Tobacco Warehouse: Fumigators (IT/CT)
Tobacco Warehouse: Aerators (ST)
Tobacco Warehouse: Aerators (IT/CT)
Tobacco Warehouse: Bystanders post aeration
(ST)
Tobacco Warehouse: Bystanders post aeration
(IT/CT)
Flat Bin: Fumigators (ST)
Flat Bin: Fumigators (IT/CT)
Farm Bin: Fumigators (ST)
Farm Bin: Fumigators (IT/CT)
Spot fumigation: Fumigators (ST)
Spot fumigation: Fumigators (IT/CT)
Spot Fumigation: Aerators (ST)
Spot Fumigation: Aerators (IT/CT)
Commodity Transfer- Product packaging line:
Bystanders post aeration (ST)
Commodity Transfer- Product packaging line:
Bystanders post aeration (IT/CT)
Commodity Transfer- Transfer of grain to bulk
cars: Bystanders post aeration (ST)
Commodity Transfer- Transfer of grain to bulk
cars: Bystanders post aeration (IT/CT)
1-Hour
71
91
150
200
340
1
3
5
17
4
5
200
230
16
120
270
440
2-Hour
36
45
77
98
170
0
1
2
8
2
2
99
110
8
59
140
220
4-Hour
18
23
38
49
86
0
1
1
4
1
1
50
57
4
29
68
110
8-Hour
9
11
19
25
43
0
0
1
2
0
1
25
29
2
15
34
56
75
(continued; footnotes follow)
-------
ST = Short Term
IT = Intermediate Term
CT = Chronic Term
Notes:
- Short term MOEs based on maximum measured concentrations from Mansdorf et. al. study
- Intermediate and chronic term MOEs based on mean concentrations from Mansdorf et. al. study
- MOEs less than 100 are generally considered to be of concern to the Agency
76 (continued; footnotes follow)
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Because the hand application of aluminum and magnesium phosphide
to animal burrows resulted in breathing zone exposures greater than the 0.03
ppm standard set forth by this document, it is considered an unacceptable
method of application without appropriate respiratory protection. It should
be noted that approximately 2 to 4 tablets were used in each application, and
that the application activities took place outdoors. Exposures are likely to be
significantly higher if the application rate is increased and/or containers are
opened in areas other than outside (e.g., inside vehicles or buildings).
e. Additional Occupational/Residential Exposure Studies
The Agency is requiring a study to explore the potential for exposure
of applicators, aerators, and occupational and residential bystanders to
phosphine gas. The reason the Agency is requesting this data is two-fold.
First, a limited amount of exposure data is available for aluminum and
magnesium phosphide exposure. Secondly, while the Mansdorf et. al. study
is considered the best available data for risk assessment, it uses a limited
number of replicates and does not measure all of the important variables
regarding potential exposures.
The monitoring data being requested must be captured for all of the
phases of fumigation: application; fumigation; and aeration. The exposure
levels of the applicator and assistants to phosphine during each of these phases
need to be documented. In addition, ambient air concentrations in the
immediate vicinity, i.e., where other personnel are working, must be
documented during each phase. Further, phosphine concentrations must be
measured outside of the structure to the limit of detection or 500 feet away
during each phase of fumigation.
f. Short Term Residential Risk
There is a limited registered residential use at the present time.
However, the Agency has proposed that this use be removed. Further, the
Agency is concerned about the potential risks to residential bystanders, which
are addressed in the occupational risk assessment.
C. Environmental Assessment
The Agency has completed its review of the available information regarding the
potential impact of aluminum and magnesium phosphide on the environment. The following
sections describe this assessment.
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1. Environmental Fate and Transport Assessment
The environmental fate and transport assessment is based upon review of
selected available literature and is not supported by guideline studies. Because of the
physical properties and use patterns of aluminum and magnesium phosphide, the
Agency has determined that no environmental fate studies are required at this time.
Aluminum phosphide (A1P) and magnesium phosphide (Mg3P2) appear to be
non-persistent under most environmental conditions, and are non-mobile in soil
because of their instability at atmospheric moisture contents. A1P and Mg3P2 react
with water or moisture in air to generate the highly toxic gas phosphine (PH3) which
is the active ingredient of these pesticides (Cotton and Wilkerson, 1988; Fluck, 1973;
Greenwood and Earnshaw, 1984; and World Health Organization, 1988). Other
products of hydrolysis are aluminum and magnesium hydroxides. The reaction can
be written as follows:
(1) A1P + 3H2O —> A1(OH)3 + PH3 or
(2) Mg3P2 + 6H2O —> 3Mg(OH)2+ 2PH3
The aluminum and magnesium hydroxide residues can further react to produce
mineral phases that are known to occur naturally in the environment (Lindsay, 1979).
Inorganic phosphate and other phosphorous oxyacids are expected to be other
products formed from the oxidation of PH3 in soils (World Health organization, 1988;
Hilton and Robinson, 1972; EFED one-line, 1998).
Under normal environmental conditions phosphine exists as a gas. The
solubility of phosphine in water at normal atmospheric pressure is approximately 340
ppm (World Health Organization, 1988) and the Ostwald solubility constant (the ratio
of the concentration in solution to the concentration in the gas phase at equilibrium)
is 0.201 (Fluck, 1983). Because of its high vapor pressure (40 mm Hg at -129.4 C)
and Henry' s Law Constant (0.1 atm m3/mol), phosphine at the soil surface is expected
to rapidly dissipate into the atmosphere (World Health Organization, 1988).
Phosphine in the atmosphere is rapidly degraded (World Health Organization,
1988). The half-life in air is approximately five hours with the mechanism of
degradation being photoreaction with hydroxy radicals. The dark half-life is
approximately 28 hours. The expected reaction products of phosphine in air are
oxyacids of phosphorous and inorganic phosphate which are non-volatile.
Several published laboratory studies suggest that phosphine below the soil
surface is quickly adsorbed and degraded (Hilton and Robinson, 1972; Eiseman et.
al., 1997; Berck and Gunther, 1970). Gaseous phosphine added to soil headspace at
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1000 mg/kg dry soil in closed containers degrades 50% after approximately five days
in air dried soil and 11 days in water saturated soil (Hilton and Robinson, 1972).
Smaller quantities of phosphine may be removed by soil through a faster mechanism
because phosphine added at a lower concentration (0.35 micrograms/kg) was
undetectable in 50 minutes (Eiseman, Glindemann, Bergman and Kuschk, 1997).
Diffusion through the soil environment is expected to be slow because phosphine is
sorbed in seconds when pushed through several types of soil in a nitrogen carrier
(Berck and Gunther, 1970). The interaction of phosphine with soil appears to be
mixed chemisorption (irreversible) and physisorption (reversible), with the extent of
each dependent on soil type.
2. Surface and Ground Water Assessments
Aluminum and magnesium phosphide are expected to degrade rapidly in the
environment to aluminum hydroxide and magnesium hydroxide and phosphine. The
Agency has determined that phosphine gas will degrade in days, and has a low
exposure potential for contaminating ground and surface water. Therefore, the
Agency concludes that a dietary exposure assessment from drinking water is not
necessary. See the discussion on page 46 for additional discussion.
3. Exposure and Risk Characterization
a. General
Aluminum phosphide and magnesium phosphide are expected to
degrade rapidly in the environment to aluminum hydroxide and magnesium
hydroxide and phosphine, the toxicant of these pesticides. It appears that
phosphine will degrade in days and is at low risk for contaminating ground or
surface waters. Phosphine near the soil surface is expected to diffuse into the
atmosphere and be removed via photodegradation. Phosphine trapped
beneath the soil surface will bind to soil, inhibiting movement, and be oxidized
to phosphates.
Given the use patterns of the pesticides and these characteristics,
aluminum and magnesium phosphide are not expected to pose a significant
ecological risk to non-target organisms or to water resources under most
circumstances, with the notable exception of some endangered species as
described in the following section.
b. Endangered Species
One use pattern of aluminum and magnesium phosphide, as a burrow
fumigant, poses a risk to threatened and endangered species of mammals and
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reptiles. The risks posed to these species occur if they are found in a burrow
that is fumigated. Because of the high degree of toxicity of phosphine gas, all
animals in a treated burrow will be killed.
In 1981, the United States Fish and Wildlife Service (USFWS)
determined that use of aluminum and magnesium phosphide as a burrow
fumigant may j eopardize the black-footed ferret, the Utah prairie dog, the San
Joaquin kit fox, the blunt-nosed leopard lizard, the eastern indigo snake, and
the desert tortoise.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning active ingredients, whether products containing the active
ingredients are eligible for reregistration. The Agency has previously identified and required
the submission of the generic (i.e. active ingredient specific) data required to support
reregistration of products containing aluminum phosphide and magnesium phosphide active
ingredients. The Agency has completed its review of these generic data, and has determined
that the data are sufficient to support reregistration of all products containing aluminum
phosphide and magnesium phosphide. Appendix B identifies the generic data requirements
that the Agency reviewed as part of its determination of reregistration eligibility of aluminum
phosphide and magnesium phosphide, and lists the submitted studies that the Agency found
acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess the
registered uses of aluminum phosphide and magnesium phosphide and to determine if
aluminum phosphide and magnesium phosphide can be used without resulting in unreasonable
adverse effects to humans and the environment. The Agency has determined that all uses of
aluminum phosphide and magnesium phosphide as specified in this document require
mitigation of the risks associated with the exposure to these pesticides. The Agency will
conduct a public process to identify the best ways to reduce the risks associated with
aluminum and magnesium phosphide exposure. This process will include a public comment
period and a stakeholder meeting. Following the conclusion of this process, the Agency will
make a final determination on the mitigation measures that must be adopted in order for
products containing aluminum and magnesium phosphide to be eligible for reregistration.
Further, it should be understood that the Agency may take appropriate regulatory action,
and/or require the submission of additional data to support the registration of products
containing aluminum phosphide and magnesium phosphide, if new information comes to the
Agency's attention or if the data requirements for registration (or the guidelines for generating
such data) change. The reregistration of particular products is addressed in Section V.
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The Agency made its reregistration eligibility determination based upon the target data
base required for reregistration, the current guidelines for conducting acceptable studies to
generate such data, published scientific literature, and the data identified in Appendix B.
B. Determination of Eligibility Decision
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredients aluminum
phosphide and magnesium phosphide, the Agency has sufficient information on the
human health effects of aluminum phosphide and magnesium phosphide and on their
potential for causing adverse effects in fish and wildlife and the environment. The
Agency has determined that all uses of aluminum phosphide and magnesium
phosphide as specified in this document require mitigation of the risks associated with
the exposure to these pesticides. The Agency will conduct a public process to identify
the best ways to reduce the risks associated with aluminum and magnesium phosphide
exposure. This process will include a public comment period and a stakeholder
meeting. Following the conclusion of this process, the Agency will make a final
determination on the mitigation measures that must be adopted in order for products
containing aluminum and magnesium phosphide to be eligible for reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of aluminum phosphide and
magnesium phosphide as specified in this document require mitigation of the risks
associated with the exposure to these pesticides. The Agency will conduct a public
process to identify the best ways to reduce the risks associated with aluminum and
magnesium phosphide exposure. This process will include a public comment period
and a stakeholder meeting. Following the conclusion of this process, the Agency will
make a final determination on the mitigation measures that must be adopted in order
for products containing aluminum and magnesium phosphide to be eligible for
reregistration.
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for aluminum
phosphide and magnesium phosphide. Where labeling revisions are imposed, specific
language is set forth in Section V.
1. Food Quality Protection Act Findings
a. Determination of Safety for U.S. Population
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The Agency has determined that the established tolerances for
aluminum phosphide and magnesium phosphide, with amendments and
changes as specified in this document, meet the safety standards under the
FQPA amendments to Section 408(b)(2)(D) for the general population. In
reaching this determination, the Agency has considered the available
information on the aggregate exposures (both acute and chronic) from non-
occupational sources, food, and drinking water.
b. Determination of Safety for Infants and Children
The Agency has determined that the established tolerances for
aluminum phosphide and magnesium phosphide, with amendments and
changes as specified in this document, meet the safety standards under the
FQPA amendments to Section 408(b)(2)(D) for infants and children. The
safety determination for infants and children considers the factors noted above
for the general population, but also takes into account the possibility of
increased dietary exposure due to the specific consumption patterns of infants
and children, as well as the possibility of increased susceptibility to the toxic
effects of phosphine gas residues in this population subgroup.
In determining whether or not infants and children are particularly
susceptible to the toxic effects from phosphine gas residues from aluminum
and magnesium phosphide, the Agency considered the completeness of the
database for developmental and reproductive effects, the nature and severity
of the effects observed, and other information.
The Agency reviewed a prenatal inhalation developmental toxicity
study in rats to determine susceptibility of infants and children to aluminum
and magnesium phosphide. No treatment-related effects were seen in
maternal body weight, body weight gain, food consumption, or gross
pathology. No developmental toxicity was seen. Thus, it was determined that
there is no increased susceptibility to in utero and/or postnatal exposure to
phosphine. Aluminum and magnesium phosphide developmental toxicity to
the offspring occurred at equivalent or higher doses than maternal toxicity.
The complete toxicology data requirements for a food-use chemical
are not required for aluminum/magnesium phosphide, since no phosphine
exposure is expected from the use pattern (i.e., fumigant). Any phosphine left
in fumigated commodities is expected to be removed by adequate aeration of
the commodities. Bound reaction products formed by reactions with
phosphine and biological materials form innocuous phosphates. Therefore,
the Agency determined that no additional toxicology studies are required for
this chemical.
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The Agency also addressed dietary (food and water) and residential
exposure considerations. Detectable residues in food have been reported in
field trials; however, these detections were attributed to food contamination.
Residues of phosphine are not expected with proper use of these chemicals.
A drinking water risk assessment was not performed for aluminum and
magnesium phosphide, since there are no concerns for ground or surface
water contamination from the use of these chemicals. There is a limited
registered residential use at the present time. However, the Agency has
proposed that this use be removed. Further, the Agency has concerns
regarding potential risks to residential bystanders as discussed in the
occupational exposure and risk assessment sections.
Based on these analyses, the Agency concluded that the lOx safety
factor for increased susceptibility of infants and children (as required by
FQPA) could safely be removed.
The Agency has not yet made a final decision concerning the possible
common mechanism of toxicity and the potential for cumulative effects of
aluminum and magnesium phosphide and other compounds. Therefore, for
the purposes of the tolerance reassessments in this RED document, the
Agency has considered the risks of aluminum and magnesium phosphide only.
In deciding to continue to make reregi strati on determinations during
the early stages of FQPA implementation, the Agency recognizes that it will
be necessary to make decisions relating to FQPA before the implementation
process is complete. In making these early, case-by-case decisions, The
Agency does not intend to set broad precedents for the application of FQPA
to its regulatory determinations. Rather, these early decisions will be made
on a case-by-case basis and will not bind the Agency as it proceeds with
further policy development and rulemaking that may be required.
If the Agency determines, as a result of this later implementation
process, that any of the determinations described in this RED are no longer
appropriate, the Agency will consider itself free to pursue whatever action
may be appropriate, including but not limited to, reconsideration of any
portion of this RED.
c. Effects to the Endocrine System
The Agency is required to develop a screening program to determine
whether certain substances (including all pesticide active ingredients and
inerts) "may have an effect in humans that is similar to an effect predicted by
a naturally occurring estrogen, or such other endocrine effect." The Agency
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is currently working with interested stakeholders, including other government
agencies, public interest groups, industry and research scientists in developing
a screening and testing program and a priority setting scheme to implement
this program. Congress has allowed three years from the passage of FQPA
(deadline of August 3, 1999) to implement this program. At that time, the
Agency may require further testing of these active ingredient and end use
products for endocrine disrupter effects.
2. Alternatives and Benefits Analysis
Integrated pest management of stored grain includes the following: pest-
resistant storage facilities, effective temperature, aeration, and moisture regulation,
sanitation, rotation of stock, monitoring of pest populations, use of chemical
protectants, and fumigation. Chemicals recommended for sanitation of empty grain
storage bins include methoxychlor, malathion, chlorpyrifos methyl, cyfluthrin,
diatomaceous earth, chloropicrin, and pyrethrins with piperonyl butoxide. Protectants
and surface treatments for grain in storage include malathion, chlorpyrifos methyl,
diatomaceous earth, Bacillus thuringiensis, DDVP, pirimiphos methyl, pyrethrins with
piperonyl butoxide, and methoprene. The above physical and chemical controls are
preventative and suppressive of infestations but not effective for disinfesting stored
grain once an infestation has started. Once an infestation has begun, fumigation is the
only effective treatment for large amounts of stored grain. Aluminum phosphide,
magnesium phosphide, methyl bromide, and carbon dioxide are the recommended
fumigants. Methyl bromide is scheduled for cancellation in 2001. Carbon dioxide is
prohibitively expensive and requires special equipment. Therefore, aluminum and
magnesium phosphide can be considered methyl bromide alternatives.
Aluminum and magnesium phosphide also is used to control rodents which can
carry various diseases including sylvanic plague. In cases where the purpose of
treatment is to control for a vector-borne disease the use would be considered a
public health use.
3. Tolerance Reassessment
Tolerances for Aluminum Phosphide Listed Under 40 CFR §180.225 (a) and
(b). §185.200. and §186.200 and Tolerances for Magnesium Phosphide Listed
Under 40 CFR §180.375 (a) and (b\ §185.3800. and §186.3800::
The tolerances established for aluminum and magnesium phosphide are
currently expressed in terms of residues of the fumigant phosphine resulting from the
use of aluminum and magnesium phosphide, respectively. Since both chemicals have
virtually identical use patterns and chemical properties, the Agency has decided to
change the current tolerance expressions. The new tolerances will simply be
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expressed in terms of residues of phosphine gas. These changes are not intended to
change the tolerances for the related compound zinc phosphide because the use
patterns for that chemical are substantially different than those for aluminum and
magnesium phosphide. These changes will be formally implemented in the near
future. At that time, the below tables will be changed to reflect the new tolerance
expression.
FQPA stipulates that tolerances for pesticide residues in all types of food (raw
or processed) be set under the same provisions of the law. Therefore, the listings of
all aluminum phosphide tolerances should be moved under 40 CFR §180.225 and
should be subdivided into Parts (a), (b), (c), and (d). Tolerances in Part (a) should be
reserved for residues in/on raw agricultural commodities resulting from postharvest
fumigation treatment. Tolerances in Part (b) should be reserved for residues in/on
raw agricultural commodities resulting from preharvest treatment of pest burrows in
agricultural and non-cropland areas. Tolerances in Part (c) should be reserved for
residues resulting from fumigation of processed foods (formerly listed under 40 CFR
§185.200). Tolerances in Part (d) should be reserved for residues resulting from
fumigation of animal feeds (formerly listed under 40 CFR §186.200).
The current end-use product labels for aluminum phosphide were examined
for the development of this RED document. The labels are in compliance with the
requirements to establish a minimum aeration interval of 48 hours before the
fumigated processed foods (except for processed brewer's rice, malt, and corn grits
stored in breweries for use in the manufacture of beer) are offered to the consumers.
Registrants who would like approval for shorter aeration periods based on forced air
ventilation may submit residue data from trials conducted in accordance with the
Agency's guidelines. Label restrictions have also been established specifying that
under no conditions should the formulations containing aluminum phosphide be used
so that they or their unreacted residues come in contact with any processed food.
Adequate data are available to reassess the established tolerances for residues
of the fumigant phosphine in/on raw agricultural and processed commodities resulting
from postharvest treatment of commodities or preharvest treatment of pest burrows
with aluminum phosphide. No adjustments in the established tolerance levels are
needed.
Summary
A summary of tolerance reassessments for aluminum and magnesium
phosphide is presented in Table 15. The Agency has recently updated the list of raw
agricultural and processed commodities and feedstuffs derived from crops (Table 1,
OPPTS GLN 860.1000). As a result of changes to this table, some commodity
definitions will be corrected. Further, since the tolerances will be combined per the
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new tolerance expression mentioned above, several tolerances will become duplicative
and thus will be revoked in the near future.
Table 15. Tolerance Reassessment Summary for Aluminum and Magnesium Phosphide.
Commodity
Current
Tolerance, ppm
Tolerance
Reassessment, ppm
Comment/
[Correct Commodity Definition]
Tolerances for Aluminum Phosphide Listed Under 40 CFR §180.225(a)
Almonds
Barley
Beans, cocoa
Beans, coffee
Cashews
Corn
Corn, pop
Cottonseed
Dates
Filberts
Millet
Nuts, Brazil
Nuts, pistachios
Oats
Peanuts
Pecans
Rice
Rye
Safflower, seed
Sesame seed
Sorghum
Soybeans
Sunflower, seed
Vegetables, seed and pod
(except soybeans)
Walnuts
Wheat
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.01
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.01
0.1
0.1
[Almond, nutmeat]
[Barley, grain]
[Cacao bean]
[Coffee, bean, green]
[Corn, field, grain]
[Corn, pop, grain]
[Cotton, seed, undelinted]
[Date, dried]
[Millet, grain]
[Brazil nuts]
[Pistachios]
[Oats, grain]
[Peanut, nutmeat]
[Rice, grain]
[Rye, grain]
[Sesame, seed]
[Sorghum, grain]
[Legume vegetables (succulent or
dried group (excluding
soybeans)]
[Wheat, grain]
Tolerances for Aluminum Phosphide Listed Under 40 CFR §180.225(b)
All RACs resulting from
preharvest treatment of
pest burrows
0.01
0.01
Tolerances for Aluminum Phosphide Listed Under 40 CFR §185.200 (c)
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Commodity
Processed foods
Current
Tolerance, ppm
0.01
Tolerance
Reassessment, ppm
0.01
Comment/
[Correct Commodity Definition]
Move to Section 180
Tolerances for Aluminum Phosphide Listed Under 40 CFR §186.200 (c)
Animal feeds
0.1
0.1
Move to Section 180
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Commodity
Current
Tolerance, ppm
Tolerance
Reassessment, ppm
Comment/
[Correct Commodity Definition]
Tolerances for Magnesium Phosphide Listed Under 40 CFR §180.375(a)
Almonds
Avocados
Bananas
Barley
Brazil nuts
Cabbage, Chinese
Cashews
Citrus citron
Cocoa beans
Coffee beans
Corn
Corn, pop
Cottonseed
Dates
Eggplants
Endive (escarole)
Filberts
Grapefruit
Kumquats
Lemons
Lettuce
Limes
Mangoes
Millet
Mushrooms
Oats
Oranges
Papayas
Peanuts
Pecans
Peppers
Persimmons
Pimentos
Pistachio nuts
0.1
0.01
0.01
0.1
0.1
0.01
0.1
0.01
0.1
0.1
0.1
0.1
0.1
0.1
0.01
0.01
0.1
0.01
0.01
0.01
0.01
0.01
0.01
0.1
0.01
0.1
0.01
0.01
0.1
0.1
0.01
0.01
0.01
0.1
0.1
0.01
0.01
0.1
0.1
0.01
0.1
0.01
0.1
0.1
0.1
0.1
0.1
0.1
0.01
0.01
0.1
0.01
0.01
0.01
0.01
0.01
0.01
0.1
0.01
0.1
0.01
0.01
0.1
0.1
0.01
0.01
Revoke
0.1
[Almond, nutmeat]
[Barley, grain]
[Cacao bean]
[Coffee, bean, green]
[Corn, field, grain]
[Corn, pop, grain]
[Cotton, seed, undelinted]
[Date, dried]
[Endive/escarole]
[Millet, grain]
[Oats, grain]
[Peanut, nutmeat]
Covered by the tolerance for
peppers.
[Pistachios]
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Commodity
Plantains
Rice
Rye
Salsify tops
Sorghum
Soybeans
Sunflower seeds
Sweet potatoes
Tangelos
Tangerines
Tomatoes
Walnuts
Wheat
Current
Tolerance, ppm
0.01
0.1
0.1
0.01
0.1
0.1
0.1
0.01
0.01
0.01
0.01
0.1
0.1
Tolerance
Reassessment, ppm
Revoke
0.1
0.1
0.01
0.1
0.1
0.1
0.01
0.01
0.01
0.01
0.1
0.1
Comment/
[Correct Commodity Definition]
Covered by the tolerance for
bananas.
[Rice, grain]
[Rye, grain]
[Salsify, tops]
[Sorghum, grain]
[Sunflower, seed]
[Wheat, grain]
Tolerances for Magnesium Phosphide Listed Under 40 CFR §180.375 (b)
All RACs resulting from
preharvest treatment of
pest burrows
0.01
0.01
Tolerances for Magnesium Phosphide Listed Under 40 CFR §185.3800 (c)
Processed foods
0.01
0.01
Move to Section 180
Tolerances for Magnesium Phosphide Listed Under 40 CFR §186.3800 (c)
Animal feeds
0.1
01
Move to Section 180
4.
Codex Harmonization
The Codex Alimentarius Commission has not established maximum residue
limits (MRLs) for aluminum and magnesium phosphide residues in/on various
commodities (see Guide to Codex Maximum Limits For Pesticide Residues, Part 2,
FAO CX/PR, 4/91). However, MRLs have been established for hydrogen phosphide
(phosphine gas). At this time there is not harmonization between MCL's and U.S.
tolerances. Provided that the registrant submits a petition (with supporting CODEX
residue data) requesting that these tolerances be reduced, the Agency anticipates that
harmonization between European MCL's and U.S. tolerances will be possible.
Harmonization of the Codex MRLs with the U.S. tolerances will be considered as part
of the efforts to redefine the tolerance expression as mentioned earlier.
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5. Summary of Risk Management Decisions
a. Human Health
(1) Dietary
Acute Dietary
After conducting a conservative acute dietary analysis, the
Agency has found that the dietary exposure and risk associated with
aluminum and magnesium phosphide is negligible. Phosphine gas will
dissipate rapidly into the atmosphere which makes residues on treated
commodities very unlikely. Additionally, aluminum and magnesium
phosphide may not be directly mixed with foods, feed, or raw
agricultural products which may be used directly as foods. Residues
also are not expected to be found in meat/milk/poultry/eggs. Further,
the endpoint selected for the risk assessment is based upon a NOEL
that was the highest dose tested in the study which means that no
toxic signs were observed at the dose used for the risk assessment and
it is possible that the true NOEL is higher than the dose level used for
the risk assessment.
Chronic Dietary
After conducting a conservative chronic dietary analysis the
Agency has found that both the chronic dietary exposure and risk
associated with aluminum and magnesium phosphide are negligible for
the reasons mentioned above.
Cancer
Since chronic dietary exposure and risk associated with the use
of aluminum and magnesium phosphide are negligible, no risk of
cancer is expected from the use of these pesticides. The final results
of the two-year oncogenicity study are expected in November 1998,
and will be reviewed to confirm this position.
(2) Worker (Mixer/Loader/Applicator)
Short-Term and Intermediate Term
Upon conducting an extensive risk assessment on over 40
scenarios, the Agency found that the risks posed to workers were
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acceptable when full PPE/SCBA was utilized. However, the use of
SCBA especially over a full 8-hour application period would be
cumbersome. Most MOEs were acceptable when PPE/full face
respirators were used for the full 8-hour application period based on
measured concentrations. All scenarios had acceptable MOEs using
the OSHA PEL. Several scenarios, however, had unacceptable MOEs
when based on mean concentrations which, together with the potential
problems surrounding the long-term use of SCBA, indicates the need
for additional mitigation measures to reduce these worker risks.
These concerns are addressed through the risk mitigation efforts
outlined in this RED.
Nearly all MOEs were unacceptable at baseline conditions (no
PPE). The potential exists for workers who are not directly
associated with the fumigation/aeration activities to be near areas
where these operations are occurring. These workers may not be
aware of these activities and/or may not be wearing the required PPE,
thus creating a potentially hazardous situation. This occupational
"bystander" risk is discussed below.
Post-Application
The Agency is concerned about potential risks to persons
entering treated areas even when following the entry restrictions found
on end-use product labels for aluminum and magnesium phosphide.
(3) Bystanders
The Agency is concerned about the potential risks to
occupational and residential bystanders with respect to the use of
aluminum and magnesium phosphide. Most worker scenarios had
unacceptable MOEs for occupational bystanders at the baseline level
(no PPE) with no scenario being acceptable for 8 hours and most not
acceptable at even 1 to 2 hours of exposure. Since nearby workers
not directly involved in the fumigation/aeration activities may not be
wearing the PPE required for fumigators and aerators, such exposures
are possible and are a concern to the Agency. Of additional concern
is the potential for exposure to residential bystanders, since there is
little likelihood of those persons wearing any PPE. In some cases,
structures and areas undergoing fumigation and aeration may be very
near to residential dwellings or other places where residential
bystanders are likely to be found. Poisoning incident data supports
the Agency's concerns for both occupational and residential bystander
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risks.
(4) Public Comment and Stakeholder Meeting Process
Given the high toxicity of aluminum and magnesium phosphide
and potential risks posed to occupational and residential bystanders,
the Agency has developed a number of mitigation measures which it
proposes in order to reduce the risks outlined in this document.
However, since aluminum and magnesium phosphide have significant
benefits and there are few if any viable alternatives besides methyl
bromide, the Agency believes that it is important that a broad
stakeholder process be conducted to discuss these measures and/or to
develop other workable mitigation measures that adequately protect
occupational and residential bystanders. Therefore, the Agency is
planning to conduct a public comment and stakeholder process to
accomplish this objective.
During the public comment period, commencing with the
publishing of a Federal Register Notice, comments and suggestions
will be collected and reviewed concerning these measures. Based
upon this input, the proposed measures will be revised as needed.
These revised mitigation measures will be discussed at a stakeholder
meeting that will be held within 9 months from the issuance of this
RED at a location to be determined. For this meeting to be most
efficient and successful, all interested parties and viewpoints will be
welcomed and considered. Following the conclusion of this process,
the Agency will make a final determination on the mitigation measures
that must be adopted in order for products containing aluminum and
magnesium phosphide to be eligible for reregi strati on. The outcomes
of this public comment and stakeholder process will effect all
aluminum and magnesium products.
(5) Proposed Risk Mitigation Measures
The following mitigation measures are proposed for all
aluminum and magnesium phosphide products. These measures are
to be discussed as part of the public review and stakeholder meeting
process mentioned above. Following each proposal is a list of generic
questions that can be used as a guide for providing input to the
Agency on particular proposals.
i. Notification of Authorities and On-site Workers
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The Agency believes that it is important that anyone who
might be expected to respond to an emergency involving aluminum an
magnesium phosphide be well prepared to quickly and effectively
respond to such a situation. Hence, the Agency is proposing that
applicators would be required to ensure that the local authorities (fire
departments, police departments etc.) are notified of the date, time,
and location of planned fumigation events at least 24 hours in advance
of beginning operations. Further, the Agency is concerned that on-site
workers not directly associated with the fumigation could be
inadvertently exposed to phosphine since they may frequent areas near
fumigated structures. To minimize the potential for inadvertent
exposures the Agency is proposing that the applicators would be
required to notify any worker or other person who might be expected
to be in the proximity of the fumigation/aeration, prior to fumigation.
* what authorities would need to be notified?
* who would be responsible for notification?
* what form or method of notification of both authorities and
workers should be employed?
* what is the appropriate timing for notifications?
ii. Requirement for Certified Applicators
The Agency believes that a properly structured certification
process provides for a high level of competence in those that are able
to complete this process. This level of competence could be difficult
to attain without completion of such a process. In order to better
ensure the safe conduct of fumigation/aeration operations, the Agency
is proposing to require that all persons who conduct these activities be
a certified applicator or that certified applicators supervising the
activity be within 50 ft of the operation and within clear sight-line of
the persons conducting the operation. Current labels allow for non-
certified fumigators and aerators to conduct activities under the direct
supervision and physical presence of a certified applicator. However,
it is possible under this current language for the certified applicator to
be a significant distance away from the actual operation, impeding
his/her ability to adequately oversee the operations. This potential
problem would be solved by requiring certified applicators to be
within 50 feet (and within clear sight lines) of persons conducting
fumigation/aeration operations.
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* when a certified applicator is supervising an operation where
should he/she be positioned with respect to the work being
done?
iii. Prohibit Aeration of Railcars, Railroad Boxcars, Other
Vehicles, and Containers En-Route.
The Agency is concerned about the possibility of exposure to
phosphine from aeration of fumigated railcars, railroad boxcars,
shipping containers, and other vehicles while in transit. This would
especially be of concern during scheduled and unscheduled stops in or
near populated areas. To ensure that these exposures do no occur,
the Agency is proposing that aeration of fumigated railcars, railroad
boxcars, shipping containers, and other vehicles while in transit would
be prohibited. Labels would be required to include this prohibition.
* what measures can be taken to prevent exposures from
aeration of fumigated railcars, railroad boxcars, shipping
containers, and other vehicles while in transit?
iv. Placarding fumigated structures, containers, and vehicles.
The Agency is concerned about potential exposure resulting
from improper entrance to fumigated vehicles that have been
fumigated prior to/during transit. While the labels require monitoring
of such vehicles prior to entry the labels are not always part of the
shipment records and the current placards do no necessarily contain
this requirement. The Agency also believes it is important that
placards contain incident reporting information so that those who
might be exposed be better able to report the incident. Currently,
labels require the placarding of structures, containers, and vehicles
that have been fumigated. The Agency is proposing as a possible
requirement that these placards, or some other documentation that
accompanies the structure/container/vehicle, clearly state that prior to
entering the structure/container/vehicle a certified applicator or trained
person under the supervision of a certified applicator (as defined
above) must monitor the concentration of phosphine therein.
Unloading where exposure to workers or bystanders is possible, or
entry must not occur until the measured concentrations are below the
pertinent standard unless appropriate PPE is worn. These placards
must also contain information for reporting incidents which is
consistent with the incident reporting program developed by the
registrants.
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* how should information be provided to persons prior to
entry into a fumigated structure or vehicle to prevent
exposure? What should that information be?
* what is the appropriate mechanism for reporting incidents
and how should that mechanism be communicated?
v. Establish an Incident Reporting Program.
The Agency believes that, given the toxicity of these chemicals
and the incident data currently available, a structured program would
need to be developed to ensure that more complete and accurate
information regarding incidents is collected and analyzed. Therefore,
the Agency is proposing that registrants would be required to establish
programs for the comprehensive reporting of incidents to the Agency
on an annual basis.
* what mechanisms can be used to report and analyze
incidents involving aluminum and magnesium phosphide?
vi. Personal Protective Equipment
Given the high level of toxicity of phosphine and the Agency's
concerns regarding the potential for exposure as outlined in this RED,
the Agency is proposing to require that all persons involved in
fumigation/aeration operations wear respiratory protection during
those operations unless it can be verified via monitoring that the
concentrations of phosphine are at or below the established standard.
PPE would be required to be worn by any person conducting
monitoring activities until concentrations are known to be below the
established limit. In the event of a spill or leak, SCBA or supplied air
would be required to be worn until the spill has been cleaned or the
leak has been repaired.
As mentioned previously, a full face respirator is not always
adequately protective, and SCBA can be cumbersome and difficult to
use over extended periods of time. Supplied air is a possible
alternative. Supplied air is defined as aNIOSH-approvedfull-faceor
hood respirator to which is supplied uncontaminated air, usually via
a hose fed by an electric compressor. The face piece or hood must be
maintained under positive pressure to maintain the maximum
protection factor.
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*what procedures could reduce the potential for exposure
during fumigation/aerationoperations?
* what equipment would provide adequate protection under
various conditions?
vii. Proposal to require two-man operation for any activity that
would involve entry into a fumigated structure.
Due to the acutely toxic effects of inhaling phosphide gas the
Agency is proposing that a minimum of two qualified persons would
be needed to carry out any fumigation requiring entry into a structure.
By implementing a two-man rule, if an applicator is unable to remove
oneself from a dangerous exposure situation the second person can
then assist in the safe removal of that person from danger. One
person would be required to be a certified applicator and one person
would need to be trained in the use of monitoring equipment and the
health effects of phosphine gas. Although phosphine gas is considered
to have good 'warning properties' because of a foul odor detectable
by smell as low as 0.02 ppm, not all persons have the same sense of
smell. Because some persons may have a poor sense of smell, and due
to the capacity for the sense of smell to be fatigued after prolonged
exposure, the fumigation workers should rely upon chemical detecting
instruments.
*what steps can be taken to ensure that an applicator is able
to exit a dangerous situation safely?
* what qualifications should the person who is acting as the
second person have?
viii. Establish 500 foot buffer zone and restricted area around all
fumigated structures
The Agency is concerned about the possibility of bystander
exposure to phosphine especially in residential areas especially
considering the toxicity of phosphine. Based upon a review of
incidents, the Agency is proposing to prohibit the fumigation and
aeration of structures that are within 500 feet of residential areas.
Further, a 500 foot restricted area would be implemented for all
areas/structures undergoing fumigation/aeration. These steps would
be taken primarily to prevent exposure to residential bystanders. Prior
to entry to this area monitoring would need to be conducted to ensure
96
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that the concentrations of phosphine in the atmosphere is less than the
0.03 ppm standard established in this RED or the limit of detection of
the best available technology. Entry would not allowed above that
concentration unless appropriate PPE is worn. Placarding would be
required to occur around the perimeter of the 500 foot restricted zone.
Efforts would need to be made to request permission for placarding
where placarding of the perimeter would involve other people's
property.
* what size buffer zone, if any, would provide adequate
protection to residential bystanders?
* what alternative measures could be put in place to achieve
protection w/o a buffer zone?
* what would be the impact on the ability to fumigate various
structures if a 500 foot zone was put in place?
* what measures could be put in place regarding railcars,
shipping containers and other vehicles to prevent bystander
exposure?
ix. Institute More Thorough Monitoring Around the Commodity
The Agency is concerned about the possibility of exposure
resulting from entry into a structure where phosphine gas pockets
have developed which normal monitoring would not detect.
Therefore, the Agency is proposing to require stringent monitoring
when unloading or otherwise disturbing a commodity that has been
fumigated, since the level of phosphine gas may be higher at the core
of the commodity than in the surrounding air. Monitoring at the door
or hatch is insufficient in some cases. Therefore, concentrations
would be required to be monitored at the top, middle, and bottom
levels of the commodity /storage facility, where feasible, because of
stratification of gasses and vapors (similar to monitoring in confined
spaces, OSHA 29 CFR 1910.146).
* what steps can be taken to ensure that there are not
"pockets" of phosphine gas within a given structure or
commodity prior to entry?
* what are the technical limitations to conducting this type of
monitoring, if any?
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x. Require Seal/Leak Testing for Fumigated Structures
The Agency believes that one potential exposure scenario
would involve leakage of phosphine, especially into adjacent
structures where people may be working/residing. For this reason the
Agency is proposing that, prior to fumigation, the structure would
undergo seal/leak testing using established methods to ensure that
leakage during fumigation will not occur or is significantly minimized.
Record of seal/leak tests must be retained by the certified applicator.
Leaks would need to be repaired prior to fumigation. Fumigation
would prohibited in cases where substantial leaks are discovered and
cannot be sealed.
* what methods are available for conducting effective leak
tests and how costly are these methods?
* what other steps could be taken to reduce the possibility of
significant leaks?
* how can substantial leakage be defined?
xi. Establish a Minimum Distance from Residences for Burrow
Use and PPE for Applicators During these Applications.
The Agency is concerned about the possibility of unintended
exposure to residents or other bystanders that might result from
rodent control uses near homes or other commercial facilities such as
hospitals, schools, and nursing homes. Therefore, the Agency is
proposing that treatment of burrows for rodent control be prohibited
within 100 feet of a residence. Note that current labels have a
restriction of 15 feet, which may not be protective if burrow tunnels
extend toward residences (basements). Applicators involved in the
fumigation of animal burrows would be required wear respiratory
protection during the course of the operation. These actions would
eliminate the residential uses of aluminum and magnesium phosphide
but would allow for rodent control to continue under other
circumstances. In cases of public health, where no other alternatives
can be found, exceptions to this item may be made.
* how can exposures to bystanders be prevents when burrows
are treated in a residential or school/hospital setting?
* what, if any, size buffer zone around residential and other
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related structures would provide adequate protection from
inadvertent exposure?
* what is the potential for seepage of phosphine into
basements during a burrow treatment?
xii. Notification of Local Residents
The Agency believes that it is important to notify local
residents near fumigated structures so that they can take actions if
they choose to protect themselves from possible phosphine exposure.
This is especially germane given the Agency's commitment to
community right to know. Therefore, the Agency is proposing to
require notification so that residents in adjoining properties can make
decisions regarding temporarily leaving their property during
fumigation. Such notification would also be required for commercial
and industrial sites that are near a planned fumigation operation. The
Agency proposes that the certified applicator would be required to
ensure that all residents are notified within 750 feet of the fumigated
structure.
* what is the most appropriate means of informing the public
of impending fumigation\aeration operations?
* how should the local area be defined for purposes of
notification? Is 750 ft. appropriate?
xiii. Requirement for Improved Training for Certified Applicators
The Agency believes that effective training and certification
programs are needed to ensure that applicators are prepared to
conduct fumigation operations safety. Since fumigation is a relatively
unique operation when compared to other agricultural and non-
agricultural pest control practices, the Agency believes that a
fumigation-specific certification program may be necessary. Although
current labels state the need for applicators to have training in
phosphine fumigation, existing training programs appear insufficient
given the high incident rate. The Agency is proposing to require that
the registrants work with the appropriate personnel in the Agency and
in the States to develop a fumigator-specific certification program that
adequately addresses all risks associated with the use of these
chemicals. These programs would stress the highly toxic nature of the
chemicals, fumigation/aeration-specific issues, and the importance of
99
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understanding and following label language exactly. Also, those
requirements that result from the outcomes of the stakeholder
meetings, must be emphasized. This effort would also include
consideration of the most effective method of delivering this training.
* is there a need for a fumigation-specific training program?
* what elements should a fumigation-specific certification
program contain?
* could existing programs be improved upon to meet these
needs or does a new program need to be developed?
* can reciprocity or standardization be achieved? should they
be achieved?
xiv. Monitoring Methods to Minimize Exposure
The Agency is concerned about exposures to phosphine given
its high toxicity. Therefore, the Agency is proposing to require
additional monitoring of areas around fumigated structures in order to
reduce the potential for occupational and residential bystander
exposure to phosphine. The Agency is further proposing to require
that no fumigated structure be entered until it can be verified that the
concentrations of phosphine present are at or below the 0.03 ppm
standard unless appropriate PPE is worn. A certified applicator or
other competent person (industrial hygienist etc.) Would be required
to conduct the monitoring. All fumigation/aeration operations would
be covered by this requirement including outdoor operations.
The Agency recognizes that current technology is not capable
of detecting phosphine at the 0.03 ppm level. Therefore, the best
available technology would be used with the limit of detection acting
as the standard until new technology becomes available at which time
the 0.03 standard would be required. The Agency is aware of a "real-
time" direct-read device technologies with a limit of detection of 0.05
ppm that are currently available. These devices can be equipped with
audible alarms and data loggers.
Further, there is evidence that the human sense of smell can
"detect" phosphine at 0.02 ppm levels (See also ix). In cases where
an employee smells the gas it will be assumed that the concentrations
are above the standard and proper precautions/actions taken. Under
100
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no circumstances should a person consider smell as a monitoring
option in lieu of device monitoring.
* what are the impacts of using the .03 ppm regulatory
standard?
* are there scientifically valid alternatives to the .03 ppm
standard?
* what would an appropriate monitoring scheme include?
* is it appropriate to monitor "outdoor" operations? why or
why not?
xv. Establi sh and Define Applicable Exposure Limits for the Label
The Agency believes that it is important that users of this
pesticide be aware of all applicable workplace standards regarding
phosphine. Therefore, the Agency is proposing to require that these
standards appear on the label. It would be clearly stated that actions
that are required currently based upon the OSHA PEL, STEL and
action levels will now be required to occur based upon the 0.03 ppm
standard established by this document.
* same questions as above.
b. Environmental/Ecological Effects
Aluminum phosphide and magnesium phosphide are expected to
degrade rapidly in the environment to aluminum hydroxide and magnesium
hydroxide and phosphine, the toxicant of these pesticides. It appears that
phosphine will degrade in days and is at low risk for contaminating ground or
surface waters. Phosphine near soil surface is expected to diffuse into the
atmosphere and be removed via photodegradation. Phosphine trapped
beneath the soil surface will bind to soil, inhibiting movement, and be oxidized
to phosphates which are common in the natural environment. Therefore,
aluminum and magnesium phosphide and their residues do not appear to be
persistent or mobile under most environmental conditions.
Given the characteristics aluminum and magnesium phosphide and
their use patterns, these pesticides are not expected to pose a significant
ecological risk to non-target organisms or to water resources under most
circumstances, with the exception of some endangered species. Since one of
101
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the uses of these pesticides is as a burrow fumigant for the control of rodents,
there is a concern that several endangered or threatened species could be
present in burrows targeted for fumigation. Since phosphine gas is highly
toxic any animals in a fumigated burrow are expected to be killed. See the
discussion below on the endangered species statement for additional
information regarding this issue.
c. Restricted Use Classification
Based on its toxicity and use patterns, the Agency is maintaining
Restricted Use classification for all aluminum and magnesium phosphide
products.
d. Endangered Species Statement
Currently, the Agency is developing a program ("The Endangered
Species Protection Program") to identify all pesticides whose use may cause
adverse impacts on endangered and threatened species, and to implement
mitigation measures to address the adverse impacts. The program would
require use restrictions to protect endangered and threatened species at the
county level. Consultations with the Fish and Wildlife Service may be
necessary to assess risks to newly listed species or from proposed new uses.
In the future, the Agency plans to publish a description of the Endangered
Species Program in the Federal Register and have available voluntary county-
specific bulletins. Because the Agency is taking this approach for protecting
endangered and threatened species, it is not imposing label modifications at
this time through the RED. Rather, any requirements for product use
modifications will occur in the future under the Endangered Species
Protection Program.
Aluminum and magnesium phosphide have been subject to a formal
consultation with the Fish and Wildlife Service, as noted in Section III of this
document. Additional consultation with the Fish and Wildlife Service may be
necessary to determine if steps need to be taken to protect newly listed species
or from proposed new uses of these pesticides.
e. Occupational Labeling Rationale
At this time, products containing aluminum and magnesium phosphide
are intended primarily for occupational use (e.g. mixed, loaded, and applied
by commercial applicators only;). The WPS does not cover the currently
labeled uses of these pesticides. Therefore, the uses of aluminum and
magnesium phosphide are NOT within the scope of WPS. A limited
102
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registered use for treatment of rodent burrows may involve applications at
residential sites. Exposure to residential bystanders is an issue of concern as
mentioned earlier.
Occupational-Use Products
The Agency is proposing a.i.-specific requirements for all occupational
handlers of aluminum and magnesium phosphide. The MOE's for inhalation
exposure were less than 100 for all occupational categories at the baseline and
for aerators, fumigators, and bystanders in a number of scenarios where PPE
was used. The Agency is proposing active-ingredient-based protections for
handlers of aluminum and magnesium phosphide in all exposure situations.
Other Labeling Requirements
The Agency is also requiring other use and safety information to be
placed on the labeling of all end-use products containing aluminum and
magnesium phosphide. For the specific labeling statements, refer to Section
V.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the reregi strati on of
both manufacturing-use and end-use products.
A. Manufacturing-Use Products
There are no manufacturing-use products (MPs) registered under Shaughnessy Nos.
066501 and 066504. There are 28 aluminum phosphide end-use products (EPs) and four
magnesium phosphide EPs. The Agency has determined that because there are no registered
MPs containing aluminum or magnesium phosphide as the sole active ingredient (TGAI), all
registered EPs containing aluminum or magnesium phosphide as the sole active ingredient are
subject to a reregistration eligibility decision. This being the case, the Agency is planning to
require a bystander exposure monitoring study as confirmatory data. This air monitoring
study is considered a non-guideline, or "special" study, and as such will be forwarded to the
registrant in a separate Data Call-in after review and clearance by the Office of Management
and Budget (OMB).
B. End-Use Products
1. Additional Product-Specific Data Requirements
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Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility has
been made. Registrants must review previous data submissions to ensure that they
meet current EPA acceptance criteria and, if not, commit to conduct new studies.
If a registrant believes that previously submitted data meet current testing standards,
then study MRID numbers should be cited according to the instructions in the
Requirement Status and Registrants Response Form provided for each product.
2. Labeling Requirements for End-Use Products
All end-use products should have clear, concise, and complete labeling
instructions. Proper labels can improve reader understanding, thereby reducing
misuse and the potential for incidents. Therefore, the Agency is requiring the
following:
Directions for Use:
Directions for Use must be stated in terms that can be easily read and
understood by the average person likely to use or supervise the use of the pesticide.
It must be presented in a format that is easy to understand and follow.
The Directions for Use section of a pesticide label must provide the necessary
information to answer four maj or categories regarding the use of the pesticide. These
four questions are:
1.) Why is the pesticide being used? For what pest(s) or problems?
2.) Where is the pesticide applied? (Where should it not be applied?)
3.) How is the pesticide applied? (What special precautions must the user take?
How much should they use?)
4.) When should the pesticide be applied?
In addition, the Agency encourages the use of graphic symbols whenever
possible to clarify the written label.
National Pesticide Telecommunications (NPTN) Hotline Number
All aluminum and magnesium phosphide labels must refer consumers to the
NPTN number for additional information. This reference must bear the specific label
language contained in the table at the end of this section.
C. Required Labeling Changes Summary Table
The following table summarizes the labeling requirements being imposed by the RED
104
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for all aluminum and magnesium phosphide products. Any use instructions on current labels
that conflict with those language below should be removed.
105
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Table 16: Risk Mitigation Labeling Changes for Aluminum and Magnesium Phosphide
Description
Required Labeling
Placement
Labeling for All Products
NPTN Phone Number
Statement of Practical Treatment
Statement of Practical Treatment
Definition of Well -Ventilated
Area
Respiratory Protection
Restriction
Prevention of Explosions
For information on this pesticide product (including health concerns, medical
emergencies, or pesticide incidents), call the National Pesticide Telecommunications
Network at 1-800-858-7378.
Symptoms of overexposure are headache, dizziness, nausea, difficult breathing, coughing,
shortness of breath, vomiting and diarrhea. Breathing difficulty may not appear until
several hours after exposure has ceased.
People who show signs of overexposure to phosphine gas, or are given any first aid
treatment due to phosphine gas, must be taken directly to a doctor or emergency treatment
facility, along with a copy of the label, the applicator's manual and/or the MSDS, which
will be provided to the attending physician.
Example(s) of a "well ventilated area" per OSHA guidelines must be included on the
label.
The certified applicator must ensure that those who require respiratory protection are part
of a Respiratory Protection Program per OSHA standards contained in 29 CFR 1910.134.
"Under no circumstances shall food, feed, and/or raw agricultural commodities which may
be used directly as foods come into contact with aluminum or magnesium phosphide."
"Hydrogen phosphide-air mixtures at concentrations above the lower flammable limit may
ignite spontaneously. Ignition of high concentrations of hydrogen phosphide can produce
a very energetic reaction. Explosions can occur under these conditions and my cause
severe personal iniurv. Never allow the buildup of hvdrosen phosphide to exceed
explosive concentrations. Do not confine spent or partially spent dust from metal
phosphide fumigants as the slow release of hydrogen phosphide from this material may
result in formation of an explosive atmosphere. Monitoring will ensure that explosive
concentrations are not exceeded."
Directions for Use
Statement of Practical Treatment
Statement of Practical Treatment
Applicator Worker and Exposure
Guideline
Respiratory Protection
Directions for Use
Recommended Dosage Rates
106
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Table 16: Risk Mitigation Labeling Changes for Aluminum and Magnesium Phosphide
Leakage from Fumigated Sites
Piling of Tablets, Pellets or Bags
"Adjacent, enclosed areas likely to be occupied must be examined to ensure that
significant leakage has not occurred."
Piling of tablets, pellets or bags or the addition of liquid to the product is prohibited.
Leakage from Fumigated Sites
Safety Recommendations and
Requirements
107
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D. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for
26 months from the date of the issuance of this Reregi strati on Eligibility Decision (RED).
Persons other than the registrant may generally distribute or sell such products for 50 months
from the date of the issuance of this RED. However, existing stocks time frames will be
established case-by-case, depending on the number of products involved, the number of label
changes, and other factors. Refer to "Existing Stocks of Pesticide Products; Statement of
Policy"; Federal Register. Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell aluminum and
magnesium phosphide products bearing old labels/labeling for 26 months from the date of
issuance of this RED. Persons other than the registrant may distribute or sell such products
for 50 months from the date of the issuance of this RED. Registrants and persons other than
registrants remain obligated to meet pre-existing Agency imposed label changes and existing
stocks requirements applicable to products they sell or distribute.
108
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VI.APPENDICES
109
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110
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APPENDIX A - Table of Use Patterns Subject to Reregistration
Appendix A is 87 pages long and is not being included in this RED. Copies of Appendix A are available upon request
per the instructions in Appendix E.
Ill
-------
112
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active ingredients within the case
Aluminum and Magnesium Phosphide covered by this Reregi strati on Eligibility Decision Document. It contains generic data
requirements that apply to Aluminum and Magnesium Phosphide in all products, including data requirements for which a
"typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they appear in 40 CFR Part
158. the reference numbers accompanying each test refer to the test protocols set in the Pesticide Assessment Guidelines,
which are available from the National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)
487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data requirements apply. The
following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record Identification (MRID) number, but may be a "GS" number if no
MRID number has been assigned. Refer to the Bibliography appendix for a complete citation of the study.
113
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114
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APPENDIX B
Data Supporting Guideline Requirements
for the Reregistration of Aluminum and Magnesium Phosphide
REQUIREMENT
USE PATTERN CITATION(S)(MRID#)
PRODUCT CHEMISTRY for
Pestcon Systems (5857-1 and 5857-2)
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of Limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-6 Boiling Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
ALL 00078353, 00144543, Data Gap
ALL 00078353, 00144543, Data Gap
ALL 00078353, 00144543
ALL 00078353, Data Gap
ALL 00078353, 00144543, Data Gap
ALL 00078353, 00144543, Data Gap
ALL 00078354, 00144543
ALL 00078354, 00144543
ALL 00078354, 00144543
ALL Not Applicable
ALL Not Applicable
ALL 00078354, 00144543
ALL Not Applicable
ALL Not Applicable
ALL Not Applicable
ALL Not Applicable
115
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Data Supporting Guideline Requirements
for the Reregistration of Aluminum and Magnesium Phosphide
REQUIREMENT
63-12 pH
63-13 Stability
63-14 Oxidizing/Reducing Action
63-15 Flamability
63-16 Explodability
63-17 Storage Stability
63-18 Viscosity
63-19 Miscibility
63-20 Corrosion Characteristics
PRODUCT CHEMISTRY for
Midland Fumigant Company(30574-l and
30574-4)
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of Limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
USE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
All
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)(MRID#)
Not Applicable
Not Applicable
Letter 4/26/93
00144543
Letter 4/26/93
00144543
Not Applicable
Not Applicable
Data Gap
40607901
40607901, Data Gap
40607901
Data Gap
40607901, Data Gap
40607901, Data Gap
40607901
40607901
116
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Data Supporting Guideline Requirements
for the Reregistration of Aluminum and Magnesium Phosphide
REQUIREMENT
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
PRODUCT
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
pH
Stability
Oxidizing/Reducing Action
Flamability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion Characteristics
CHEMISTRY for
USE PATTERN CITATION(S)(MRID#)
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
All
ALL
ALL
40607901
Not Applicable
Not Applicable
40607901
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Data Gap
40607901
Data Gap
40607901
Not Applicable
Not Applicable
Data Gap
Midland Fumigant Company(30574-9,
30574-10 and 30574-11)
117
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Data Supporting Guideline Requirements
for the Reregistration of Aluminum and Magnesium Phosphide
REQUIREMENT
USE PATTERN CITATION(S)(MRID#)
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of Limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-6 Boiling Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 pH
63-13 Stability
63-14 Oxidizing/Reducing Action
63-15 Flamability
63-16 Explodability
ALL 00153941,40610401
ALL 00153941, 40610401, Data Gap
ALL 00153941,40610401
ALL 00153941, Data Gap
ALL 40610401, Data Gap
ALL 00153941, 40610401, Data Gap
ALL 40610401
ALL 40610401
ALL 40610401
ALL Not Applicable
ALL Not Applicable
ALL 40610401
ALL Not Applicable
ALL Not Applicable
ALL Not Applicable
ALL Not Applicable
ALL Not Applicable
ALL Not Applicable
ALL 40610401
ALL 40610401
ALL 00153941
118
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Data Supporting Guideline Requirements
for the Reregistration of Aluminum and Magnesium Phosphide
REQUIREMENT
63-17 Storage Stability
63-18 Viscosity
63-19 Miscibility
63-20 Corrosion Characteristics
PRODUCT CHEMISTRY for
Midland Fumigant Company(30574-5,
30574-6, 30574-7 and
30574-8)
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of Limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-6 Boiling Point
63-7 Density
63-8 Solubility
USE PATTERN
ALL
All
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)(MRID#)
00153941
Not Applicable
Not Applicable
00153941
Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
Not Applicable
Not Applicable
Data Gap
Not Applicable
119
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Data Supporting Guideline Requirements
for the Reregistration of Aluminum and Magnesium Phosphide
REQUIREMENT
63-9 Vapor Pressure
63-10 Dissociation Constant
63- 1 1 Octanol/Water Partition
63-12 pH
63-13 Stability
63-14 Oxidizing/Reducing Action
63-15 Flamability
63-16 Explodability
63-17 Storage Stability
63-18 Viscosity
63-19 Miscibility
63-20 Corrosion Characteristics
PRODUCT CHEMISTRY for
Degesch America Inc.(40285-l, 40285-
3,40285-13 and 40285-14)
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of Limits
USE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
All
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)(MRID#)
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Data Gap
Data Gap
Data Gap
Data Gap
Not Applicable
Not Applicable
Data Gap
41421201
41421201
41421201
Data Gap
41421201
120
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Data Supporting Guideline Requirements
for the Reregistration of Aluminum and Magnesium Phosphide
REQUIREMENT
USE PATTERN CITATION(S)(MRID#)
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
pH
Stability
Oxidizing/Reducing Action
Flamability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion Characteristics
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
All
ALL
ALL
41421201, Data Gap
41421201
41421201
41421201
Not Applicable
Not Applicable
41421201
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
41421201
41421201
41421201
41421201
Not Applicable
Not Applicable
Data Gap
121
-------
Data Supporting Guideline Requirements
for the Reregistration of Aluminum and Magnesium Phosphide
REQUIREMENT
USE PATTERN CITATION(S)(MRID#)
PRODUCT CHEMISTRY for
Casa Bernardo (43743-1,43743-2, and
43743-3)
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
Preliminary Analysis
Certification of Limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
40418701, Data Gap
00115159,40418701
00115158,00115159,
40418701
40418701
40418701, Data Gap
00115158,00115159,
40418701, Data Gap
00115158,00115159,
40418701
00115158,40418701
00115158,00115159,
40418701
Not Applicable
Not Applicable
00115158
Not Applicable
Not Applicable
Not Applicable
122
-------
Data Supporting Guideline Requirements
for the Reregistration of Aluminum and Magnesium Phosphide
REQUIREMENT
USE PATTERN CITATION(S)(MRID#)
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Octanol/Water Partition
pH
Stability
Oxidizing/Reducing Action
Flamability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion Characteristics
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
PRODUCT CHEMISTRY for
Inventa Corporation (59209-1, 59209-2, and
59209-3)
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of Limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
Not Applicable
Not Applicable
Not Applicable
Letter 5/25/93
00115158,40418701
40418701
00115158,40418701
Not Applicable
Not Applicable
00115158
40954901, 40954902
40954901, 42912901, Data Gap
40954901
40954902, Data Gap
40954901, 40954902, Data Gap
40954902, Data Gap
40954903
40954903
123
-------
Data Supporting Guideline Requirements
for the Reregistration of Aluminum and Magnesium Phosphide
REQUIREMENT
USE PATTERN CITATION(S)(MRID#)
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
pH
Stability
Oxidizing/Reducing Action
Flamability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion Characteristics
PRODUCT CHEMISTRY for
Inventa Corporation (59209-8)
61-1 Chemical Identity
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
All
ALL
ALL
40954903
Not Applicable
Not Applicable
40954903
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
40954903, Data Gap
Data Gap
Data Gap
40954903
Not Applicable
Not Applicable
Data Gap
ALL
00126205, Data Gap
124
-------
Data Supporting Guideline Requirements
for the Reregistration of Aluminum and Magnesium Phosphide
REQUIREMENT
USE PATTERN CITATION(S)(MRID#)
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of Limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-6 Boiling Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 pH
63-13 Stability
63-14 Oxidizing/Reducing Action
63-15 Flamability
63-16 Explodability
63-17 Storage Stability
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
00126205, 41723901
00126205, 41723901
Data Gap
00126205, Data Gap
00126205, Data Gap
00126205
00126205
00126205
Not Applicable
Not Applicable
00126205
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Data Gap
00126205
00126205
00126205
125
-------
Data Supporting Guideline Requirements
for the Reregistration of Aluminum and Magnesium Phosphide
REQUIREMENT
USE PATTERN CITATION(S)(MRID#)
63-18
63-19
63-20
Viscosity
Miscibility
Corrosion Characteristics
All
ALL
ALL
Not Applicable
Not Applicable
00126205
PRODUCT CHEMISTRY for
Inventa Corporation (59209-8)
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of Limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-6 Boiling Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
00126205, Data Gap
00126205, 41723901
00126205, 41723901
Data Gap
00126205, Data Gap
00126205, Data Gap
00126205
00126205
00126205
Not Applicable
Not Applicable
00126205
Not Applicable
Not Applicable
Not Applicable
126
-------
Data Supporting Guideline Requirements
for the Reregistration of Aluminum and Magnesium Phosphide
REQUIREMENT
63- 1 1 Octanol/Water Partition
63-12 pH
63-13 Stability
63-14 Oxidizing/Reducing Action
63-15 Flamability
63-16 Explodability
63-17 Storage Stability
63-18 Viscosity
63-19 Miscibility
63-20 Corrosion Characteristics
PRODUCT CHEMISTRY for
Inventa Corporation (59209-9, 59209-10,
59209-11, and
59209-12)
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of Limits
62-3 Analytical Method
USE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
ALL
All
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)(MRID#)
Not Applicable
Not Applicable
Not Applicable
Data Gap
00126205
00126205
00126205
Not Applicable
Not Applicable
00126205
00126205, Data Gap
00126205, Data Gap
00126205
Not Applicable
00126205, Data Gap
00126205, Data Gap
127
-------
Data Supporting Guideline Requirements
for the Reregistration of Aluminum and Magnesium Phosphide
REQUIREMENT
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
pH
Stability
Oxidizing/Reducing Action
Flamability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion Characteristics
USE PATTERN CITATION(S)(MRID#)
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
All
ALL
ALL
00126205
00126205
00126205
Not Applicable
Not Applicable
00126205
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Data Gap
00126205
00126205
00126205
Not Applicable
Not Applicable
00126205
128
-------
Data Supporting Guideline Requirements
for the Reregistration of Aluminum and Magnesium Phosphide
REQUIREMENT
USE PATTERN CITATION(S)(MRID#)
PRODUCT CHEMISTRY for
Degesch America Inc.(40285-8 and 40285-
12)
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of Limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-6 Boiling Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 pH
63-13 Stability
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
41421202
41421202
41421202
Data Gap
41421202
41421202, Data Gap
41421202
41421202
41421202
Not Applicable
Not Applicable
41421202
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
129
-------
Data Supporting Guideline Requirements
for the Reregistration of Aluminum and Magnesium Phosphide
REQUIREMENT
63-14 Oxidizing/Reducing Action
63-15 Flamability
63-16 Explodability
63-17 Storage Stability
63-18 Viscosity
63-19 Miscibility
63-20 Corrosion Characteristics
PRODUCT CHEMISTRY for
Inventa Corporation(59209-4 and 59209-6)
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of Limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-6 Boiling Point
USE PATTERN
ALL
ALL
ALL
ALL
All
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)(MRID#)
41421202
41421202
41421202
41421202
Not Applicable
Not Applicable
Data Gap
43024001
43024001
43024001
Data Gap
43024001
Data Gap
Data Gap
41692102, 43024002
Data Gap
Not Applicable
Not Applicable
130
-------
Data Supporting Guideline Requirements
for the Reregistration of Aluminum and Magnesium Phosphide
REQUIREMENT
63-7
63-8
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
pH
Stability
Oxidizing/Reducing Action
Flamability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion Characteristics
USE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)(MRID#)
41692102, 43024002
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
Not Applicable
41692102, 43024002
Not Applicable
Data Gap
41692102, 43024002
Not Applicable
Not Applicable
Data Gap
TOXICOLOGY
81-1 Acute Oral Toxicity - Rat
81-2
81-3
Acute Dermal Toxicity - Rabbit/Rat
Acute Inhalation Toxicity - Rat
A,B,C,K,
L,M
A,B,C,K,
L,M
A,B,C,K,
L,M
Waived
Waived
05007354, 41377001
131
-------
Data Supporting Guideline Requirements
for the Reregistration of Aluminum and Magnesium Phosphide
REQUIREMENT
USE PATTERN CITATION(S)(MRID#)
81-4 Primary Eye Irritation - Rabbit
81-5 Primary Dermal Irritation - Rabbit
81-6 Dermal Sensitization - Guinea Pig
81-8 Acute Neurotoxicity - Rat
82-4 90-Day Inhalation - Rat
82-7 90-Day Neurotoxicity - Rat
83-3A Developmental Toxicity - Rat
83-4 2-Generation Reproduction - Rat
83-5 Combined chronic/oncogenicity - rats
84-2A Gene Mutation (Ames Test)
84-2B Structural Chromosomal Aberration
84-4 Other Genotoxic Effects
ENVIRONMENTAL FATE
A,B,C,K,
L,M
A,B,C,K,
L,M
A,B,C,K,
L,M
A,B,C,K,
L,M
A,B,C,K,
L,M
A,B,C,K,
L,M
A,B,C,K,
L,M
A,B,C,K,
L,M
A,B,C,K,
L,M
A,B,C,K,
L,M
A,B,C,K,
L,M
A,B,C,K,
L,M
Waived
Waived
Waived
44139001, Data Gap
41413101
44210401, Data Gap
41377002
Waived
44415101, Data Gap
41434301
41434302
42788101
132
-------
Data Supporting Guideline Requirements
for the Reregistration of Aluminum and Magnesium Phosphide
REQUIREMENT
USE PATTERN CITATION(S)(MRID#)
161-1
163-3
Hydrolysis
Volatility (Lab)
RESIDUE CHEMISTRY
171-3 Directions for Use
171-4A
171-4C
171-4E
171-4J
Nature of Residue - Plants
Residue Analytical Method - Plants
Storage Stability
Meat, Milk, Poultry and Eggs
A,B,C,K,
L,M
A,B,C,K,
L,M
A,B,C,K,
L,M
A,B,C,K,
L,M
A,B,C,K,
L,M
A,B,C,K,
L,M
A,B,C,K,
L,M
00153943
00153943
00005813, 00155684,
05007621, 05008303,
05008840,05012115,
05013027, 05015384,
05018681, 05020467
05007190, 05007724,
05007845
Waived
Waived
133
-------
Data Supporting Guideline Requirements
for the Reregistration of Aluminum and Magnesium Phosphide
REQUIREMENT
USE PATTERN CITATION(S)(MRID#)
171-4K
Crop Field Trials
A,B,C,K,
L,M
00005671, 00005685,
00005686, 00005719,
00005750, 00005767,
00005781, 00005783,
00005905, 00005935,
00006724, 05007190,
05007830, 05007845,
05012293, 05013276,
05013439, 05014054,
05015520, 05016260,
05016893, 05019407,
05020467, 05020562,
05022032
171-4L
Processed Food/Feed
A,B,C,K,
L,M
00005750, 00005768,
00005774, 00005775,
00005776, 00005777,
00005786, 00005905,
00005935, 00020578,
00022007, 00022008,
00022015, 00022017,
00022026, 00022913,
05007190, 05012293,
05022032
171-4M
Multiresidue Methods
A,B,C,K,
L,M
Waived
134
-------
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies considered relevant by
EPA in arriving at the positions and conclusions stated elsewhere in the Reregistration Eligibility Document.
Primary sources for studies in this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources including the published literature,
in those instances where they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of published materials,
this corresponds closely to an article. In the case of unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a distinct title (or at least a single
subject), can stand alone for purposes of review and can be described with a conventional bibliographic citation.
The Agency has also attempted to unite basic documents and commentaries upon them, treating them as a single
study.
3. IDENTIFICATION OF ENTRIES The entries in this bibliography are sorted numerically by Master Record
Identifier, or "MRID number". This number is unique to the citation, and should be used whenever a specific
reference is required. It is not related to the six-digit "Accession Number" which has been used to identify
volumes of submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases, entries
added to the bibliography late in the review may be preceded by a nine character temporary identifier. These
entries are listed after all MRID entries. This temporary identifying number is also to be used whenever specific
reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists of a citation
containing standard elements followed, in the case of material submitted to EPA, by a description of the earliest
known submission. Bibliographic conventions used reflect the standard of the American National Standards
Institute (ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen to show a personal
author. When no individual was identified, the Agency has shown an identifiable laboratory or testing
facility as the author. When no author or laboratory could be identified, the Agency has shown the first
submitter as the author.
b. Document date. The date of the study is taken directly from the document. When the date is followed by
a question mark, the bibliographer has deduced the date from the evidence contained in the document.
When the date appears as (19??), the Agency was unable to determine or estimate the date of the
document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to create or enhance a
document title. Any such editorial insertions are contained between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing parentheses include (in
addition to any self-explanatory text) the following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears immediately following the
word "received."
135
-------
(2) Administrative number. The next element immediately following the word "under" is the
registration number, experimental use permit number, petition number, or other administrative
number associated with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing parentheses
identifies the EPA accession number of the volume in which the original submission of the study
appears. The six-digit accession number follows the symbol "CDL," which stands for "Company
Data Library." This accession number is in turn followed by an alphabetic suffix which shows the
relative position of the study within the volume.
136
-------
BIBLIOGRAPHY
MRID
CITATION
00005671 Wagner, R.M. (1962) Determination of Phosphine Residues in Commercial Wheat Flour: Project #:
20-0222-33. (Unpublished study received Jan 17, 1962 under 5857-1; prepared by Hazleton Nuclear
Science Corp., submitted by Phostoxin Sales, Inc., Alhambra, Calif.; CDL:022502-A)
00005685 Bruce, R.B. (1958) Bake-out Studies—Phostoxin Treated Grain; Residue Analysis—Phostoxin Treated
Grain-Kansas; Supplement to Report Dated Apr 30, 1958. (Unpublished study received Sep 25, 1958
under 5857-1; prepared by Hazleton Laboratories, Inc. for Hollywood Termite Control Co., Inc.,
submitted by Phostoxin Sales, Inc., Alhambra, Calif; CDL:025959-C)
00005686 Sullivan, J.B. (1969) Fumigation of and Determination of Phosphine Residues in Flue-Cured Tobacco
Samples: Final Report. (Unpublished study received Feb 4, 1969 under 5857-2; prepared by Hazleton
Laboratories, Inc. for Hollywood Termite Control Co., Inc., submitted by Phostoxin Sales, Inc.;
CDL:007792-B)
00005719 Leesch, J.G. (1974) Fumigations of Farmers Stock Peanuts with Phosphine Derived from Aluminum
phosphide: Progress Report No. 1. (Unpublished study including letter dated Apr 18, 1974 from J.G.
Leesch to J.O. Hibbard, received May 10, 1974 under 2548-59; prepared by U.S. Agricultural Research
Service, Southern Region, Stored-Product Insects Research and Development Laboratory, Chemical
Control Research Unit, submitted by Research Products Co., Salina, Kans.; CDL:009822-F)
00005750 Rosebrook, D. (1972) Evaluation of Phosphine Preparation Detia Gas EX-B, Final Report: MRI Project
No. 3502-C. Includes four methods dated Jan 20, 1972. (Unpublished study received May 2, 1972
under 2548-59; prepared by Midwest Research Institute, submitted by Research Products Co., Salina,
Kans.; CDL:006384-A)
00005767 Bruce, R.B. (1959) Residue Study-Milo: Supplement to Reports Dated April 30, 1958, September 19,
1958, September 22, 1958, and October 17, 1958. (Unpublished study received May 12, 1959 under
5857-1; prepared by Hazleton Laboratories, Inc. for Hollywood Termite Control Co., Inc., submitted by
Phostoxin Sales, Inc., Alhambra, Calif; CDL:022505-B)
00005768 Bruce, R.B. (1958) Phosphine Residues in Wheat Oil; Recovery of Phosphine: Supplement to Reports
Dated April 30, 1958 and September 19, 1958. (Unpublished study including letter dated Oct 15, 1958
from H. Rauscher to U.S. Food and Drug Administration and Pesticide Regulations Section, received Oct
20, 1958 under 5857-1; prepared by Hazleton Laboratories, Inc. for Hollywood Termite Control Co.,
Inc., submitted by Phostoxin Sales, Inc., Alhambra, Calif; CDL:022506-A)
00005774 Sullivan, J.B. (1966) Phosphine Residues from Phostoxin-Fumigated Food Samples. (Unpublished study
including letter dated Sep 12, 1973 from J.B. Sullivan to E.A.R. Liscombe, received May 6, 1974 under
5857-4; prepared by Hazleton Laboratories, Inc. for Hollywood Termite Control Co., Inc., submitted by
Phostoxin Sales, Inc., Alhambra, Calif; CDL:009879-A)
137
-------
BIBLIOGRAPHY
MRID
CITATION
00005775 Sullivan, J.B. (1966) Phosphine Residues from Phostoxin Treated Feed and Food Samples. (Unpublished
study received May 6, 1974 under 5857-4; prepared by Hazelton Laboratories, Inc. for Hollywood
Termite Control Co., Inc., submitted by Phostoxin Sales, Inc., Alhambra, Calif; CDL:009879-B)
00005776 Sullivan, J.B. (1966) Phosphine Residues from Phostoxin Treated Cereals. (Unpublished study received
May 6, 1974 under 5857-4; prepared by Hazleton Laboratories, Inc. for Kellogg Co., submitted by
Phostoxin Sales, Inc., Alhambra, Calif; CDL:009879-C)
00005777 Hild, K.; Mayr, G. (1964) Recovery Test: [Aluminum phosphide]. Includes three methods dated Sep 8,
1964 entitled: Analytical Determination of ALP (in Form of PH43A) with a Modified White and Bushey
Method, Analytical Method for the Determination of Vitamin A, and Analytical Method for the
Determination of Vita min B2 (Riboflavin). (Unpublished study received May 6, 1974 under 5857-4;
prepared by Deutsche Gesellschaft fuer Schaedlingsbekaempfung m.b.H., submitted by Phostoxin Sales,
Inc., Alhambra, Calif; CDL:009859-E)
00005781 Sullivan, J.B. (1972) Analyses of Fumigated Deglet Noor Dates for Phosphine Residues. (Unpublished
study received May 6, 1974 under 5857-4; prepared by Hazleton Laboratories, Inc. for U.S. Dept. of
Agriculture, submitted by Phostoxin Sales, Inc., Alhambra, Calif; CDL:009879-K)
00005783 Sullivan, J.B. (1973) Final Report: Determination of Phosphine Residues in Unprocessed Adriatic Figs
and Inshell Almonds. (Unpublished study including letters dated Nov 9 and 21, 1972 from H.D. Nelson
to J.B. Sullivan, received May 6, 1974 under 5857-4; prepared by Hazleton Laboratories, Inc., for U.S.
Agricultural Research Service; submitted by Phostoxin Sales, Inc., Alhambra, Calif; CDL:009879-M)
00005786 Sullivan, J.B. (1969) Final Report: Determination of Phosphine Residues in Egg Yolk Samples: Project
No. 129-156. (Unpublished study including letter dated Dec 7, 1972 from L. Shipman to E.A. Lipscomb
[sic], received May 6, 1974 under 5857-4; prepared by Hazleton Laboratories, Inc. for General Foods
Corp., submitted by Phostoxin Sales, Inc., Alhambra, Calif; CDL:009879-S)
00005813 Fluck, E. (1973) The Fate of Phosphine in the Atmosphere. (Unpublished study received Apr 27, 1976
under 5857-5; prepared by Univ. Stuttgart, Institut fuer Anorganische Chemie; submitted by Phostoxin
Sales, Inc., Alhambra, Calif; CDL:234588-C)
00005905 Bruce, R.B. (1958) Phosphine Residues on Grain. (Unpublished study received Oct 20, 1961 under
5857-1; prepared by Hazleton Laboratories, Inc. for Hollywood Termite Control Co., Inc., submitted by
Phostoxin Sales, Inc., Alhambra, Calif; CDL:120707-A)
00005935 Dieterich, W.H.; Mayr, G.; Hild, K.; Sullivan, J.B.; Murphy, J. (1967) Hydrogen phosphide as a fumigant
for foods, feeds and processed food products. Pages 135-149,InResidue Reviews: Volume 19. New
York: Springer-Verlag. (Also In unpublished submission received Sep 25, 1969 under OF0890;
submitted by Hawaii, Dept. of Agriculture, Honolulu, Hawaii; CDL:093187-V)
138
-------
BIBLIOGRAPHY
MRID
CITATION
00006000 Hackenberg, U. (1972) Chronic ingestion by rats of standard diet treated with Aluminum phosphide.
Toxicology and Applied Pharmacology 23(1): 147-158. (Also~In~unpublished submission received Apr
23, 1976 under 6704-78; submitted by U.S. Dept. of Interior, Fish and Wildlife Service, Washington,
D.C.; CDL:224029-G)
00006724 Sullivan, J.B. (1972) Phosphine Residue and Recovery Studies in Corn, Milo, Wheat and Rye Grains.
(Unpublished study received on unknown date under unknown admin, no.; prepared by Hazleton
Laboratories for Phostoxin Sales, Inc., submitted by ?; CDL: 098463-B)
00020578 Hild, K.; Mayr, G. (1965) Fumigation of Processed Food with Phostoxin-Pellets under Gaslight
Tarpaulin and Determination of Aeration Time: Laboratory Report No. 6501. (Unpublished study
received on unknown date under 5H1650; prepared by Deutsche Gesellschaft fear
Schaedlingsbekaempfung m.b.H., submitted by Hazleton Laboratories, Inc., Falls Church, Va.;
CDL:221604-C)
00022007 Sullivan, J.B.; Starr, ? (1966) Phosphine Residues from Phostoxin Treated Processed Dried Fruits.
(Unpublished study received Apr 5, 1972 under 2F1184; prepared by Hazleton Laboratories, Inc. for
Hollywood Termite Control Co., Inc., submitted by Phostoxin Sales, Inc., Alhambra, Calif;
CDL:090995-B)
00022008 Sullivan, J.B.; Wooldridge, ? (1967) Phosphine Residues from Phostoxin Treated Rice Polish, Mixed
Cereal, Teething Biscuits, Meat Sticks, and Junior Beef. (Unpublished study received Apr 5, 1972 under
2F1184; submitted by Phostoxin Sales, Inc., Alhambra, Calif; CDL:090995-C)
00022015 Sullivan, J.B.; Sucher, ; Hohing, (1969) Final Report: Determination of Phosphine Residues in Spice
Samples: Project No. 990-103. (Unpublished study including letter dated Apr 17, 1969 from J.B.
Sullivan to Douglas H. Ackerman, received Apr 5, 1972 under 2F1184, submitted by Phostoxin Sales,
Inc., Alhambra, Calif; CDL:090995-L)
00022017 Sullivan, J.B.; Tacey, ; Sucher, (1969) Fumigation of and Determination of Phosphine Residues in Whole
Almonds, Walnuts, Raw Peanuts and Roasted Peanuts: Final Report. (Unpublished study received Apr 5,
1972 under 2F1184, prepared by Hazleton Laboratories, Inc. for Hollywood Termite Control Co., Inc.,
submitted by Phostoxin Sales, Inc., Alhambra, Calif; CDL:090995-O)
00022026 Sullivan, J.B.; Wooldridge, (1966) Phosphine Residues from Phostoxin-Fumigated Food Samples.
(Unpublished study received Jan 21, 1967 under 6F0508; prepared by Hazleton Laboratories, Inc.,
submitted by Phostoxin Sales, Inc., Alhambra, Calif; CDL: 090598-H)
00022913 Murphy, J.B.; Tacey, (1968) Final Report: Phosphine Residues from Phostoxin Treated Chocolate
Products. (Unpublished study received Apr 5, 1972 under 2F1184; prepared by Hazleton Laboratories,
Inc. for Vogel-Ritt, Inc., submitted by Phostoxin Sales, Inc., Alhambra, Calif; CDL:090995-R)
139
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BIBLIOGRAPHY
MRID
CITATION
00026937 Hackenberg, U. (1969) Investigation Report: 2 Years Toxicity Studies with PhostoxinA(R)4-Treated
Food on Rats. (Unpublished study received Aug 2, 1971 under 2F1184; prepared by Institut fur
Industrielle und Biologische Forschung, submitted by Phostoxin Sales, Inc., Alhambra, Calif.;
CDL:221725-L)
00026938 Hackenberg, U. (1971) Chronic Ingestion by Rats of Standard Diet Treated with Aluminum phosphide.
(Unpublished study received Aug 2, 1971 under 2F1184; prepared by Institut fuer Industrielle und
Biologische Forschung, submitted by Phostoxin Sales, Inc., Alhambra, Calif; CDL:221725-M)
00078353 Pestcon Systems, Incorporated (19??) ?Chemistry of Fumitoxin Pellets/Tabletso: Lab Log 71072.
Includes undated methods entitled: Determination of ammonia nitrogen in metal phosphide fumigants;
Determination of pharmaceutical grade inert ingredient Phostoxin(R); Determination of aluminum
phosphide in Phostoxin; Simultaneous determination of inert ingredients in metal phosphide fumigants.
Unpublished study; 4 p.
00115158 Casa Bernardo Ltd. (1982) Reregi strati on of Pesticides Containing the Active Ingredient Aluminum
Phosphide. Product Specific Data—Table C. (Compilation; unpublished study received Sep 3, 1982 under
43743-1; CDL:248389-A)
00115159 Casa Bernardo Ltd. (1982) Reregi strati on of Pesticides Containing the Active Ingredient Aluminum
Phosphide. Generic Data—Table A. (Compilation; unpublished study received Sep 3, 1982 under
43743-1; CDL:248390-A)
00126205 Research Products Co. (1982) [Chemical Study: Detia Gas-Ex-B]. (Compilation; unpublished study
received Jan 10, 1983 under 2548-59; CDL:249616-A).
00153941 Inventa Corp. (1983) Product and Manufacturing Process of Aluminium Phosphide. Unpublished
compilation. 38 p.
00153943 Phos-fume Chemical Co. (1982) Product Performance Data Phosphine. Unpublished compilation. 77 P.
00155684 Shaheen, D. (1982) Nature of Residues Arising from Fumigation of Food Commodities with Metal
Phosphide Fumigants. Unpublished study prepared by Degesch America, Inc. 9 p.
05007190 Bruce, R.B.; Robbins, A.J.; Tuft, T.O. (1962) Phosphine residues from phostoxin-treated grain. Journal
of Agricultural and Food Chemistry 10(1):18-21.
05007354 Waritz, R.S.; Brown, R.M. (1975) Acute and subacute inhalation toxicities of phosphine,
phenylphosphine and triphenylphosphine. American Industrial Hygiene Association Journal
36(6):452-458.
05007621 Robinson, J.R. (1972) Residues containing phosphorus following phosphine treatment: measurement by
neutron activation. Journal of Stored Products Research 8(1): 19-26.
140
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BIBLIOGRAPHY
MRID
CITATION
05007724 Nowicki, T.W. (1978) Gas-liquid chromatography and flame photometric detection of phosphine in
wheat. Journal of the Association of Official Analytical Chemists 61(4):829-836.
05007830 Muthu, M.; Kashi, K.P.; Majumder, S.K. (1978) A simple method of determining the sorption affinity of
foodstuffs to phosphine. Chemistry and Industry (4): 129-131.
05007845 Dumas, T. (1978) Modified gas chromatographic determination of phosphine. Journal of the Association
of Official Analytical Chemists 61(l):5-7.
05008303 Dieterich, W.H.; Mayr, G.; Hild, K.; Sullivan, J.B.; Murphy, J. (1967) Hydrogen phosphide as a
fumigant for foods, feeds and processed food products. Pages 135-149,~In~Residue Reviews. Vol. 19.
Edited by F.A. Gunther. New York: Springer.
05008840 Tkachuk, R. (1972) Phosphorus residues in wheat due to phosphine fumigation. Cereal Chemistry
49(3):258-267.
05012115 Fluck, E. (1973) The chemistry of phosphine. Pages 1-64, In Inorganic Chemistry. New York:
Springer-Verlag. (Topics in current chemistry, no. 35)
05012293 Dhaliwal, G.S.; Lai, R. (1974) Studies on the behaviour, sorption and residues of phosphine in fumigated
commodities. Bulletin of Grain Technology 12(1): 14-24.
05013027 Robinson, J.R.; Bond, E.J. (1970) The toxic action of phosphine-studies with 324PH43; terminal
residues in biological materials. Journal of Stored Products Research 6(2): 133-146.
05013276 Panetsos, A.; Kilikidis, S. (1973) Toxicotis kai ypolimatiki drasis tou phostoxin [Toxicity and residual
effects of phostoxin] Chemika Chronika, Genike Ekdosis. [Chemical Chronicle, General Edition.]
38(7): 146-149.
05013439 Vardell, H.H.; Cagle, A.; Cooper, E. (1973) Phosphine residues on soybeans fumigated with aluminum
phosphide. Journal of Economic Entomology 66(3):800-801.
05014054 Rohrlich, M.; Breyer, D. (1970) Ueber Silobegasung von Weizen mit Phosphorwasserstoff
(Detia-Gas-Ex-B) [Fumigation of wheat in silos with phosphine (Detia-Gas-Ex-B)] Muehle
107(35):519-520.
05015384 Disney, R.W.; Fowler, K.S. (1972) Residues in cereals exposed to hydrogen phosphide. Pages
99-101,~In~Radiotracer Studies of Chemical Residues in Food and Agriculture, Proceedings of a
Combined Panel and Research Coordination Meeting; Oct 25-29, 1971, Vienna, Austria. Vienna,
Austria: International Atomic Energy Agency.
05015520 Breyer, D. (1973) Untersuchungen der Phosphorwasserstoffrueckstaende in Getreidenach der
Behandlung mit pulverfoermigen Begasungs-Praeparaten_ [Analyses of phosphine residues in cereals
141
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BIBLIOGRAPHY
MRID
CITATION
after treatment with powdered fumigating productsj Die Muehle + Mischfuttertechnik. [The Mill +
Mixed Feed Technology.] 110(43):699-700.
05016260 Guvener, A.; Ahmet, F.; Iz, Y. (1970) Phostoxin'le ilacli bazi hububat cesitleri ve fmdiklarda phosphin
bakiyelerinin arastirilmasi_ [Investigation of phosphine residues in cereals and hazelnuts after fumigation
with phostoxin tabletsj Bitki Koruma Bulteni. [Plant Protection Bulletin.] 10(4):242-250.
05016893 Rohrlich, M.; Meuser, F. (1969) Untersuchungen an mit Phosphorwasserstoff begastem Getreide II
Mitteilung: Technologische Aspekte der Begasung mit Phostoxin-Pellets [Research on grain fumigated
with hydrogen phosphide Report II: technological aspects of fumigation with Phostoxin pellets_]
Getreide und Mehl 19(2):9-14.
05018681 Freyman, I.R.; Sosedov, N.I. (1957) Vliyaniye fosforistogo vodoroda na kachestvo pshenitsy_ [The
effect of phosphine on the quality of wheat_] Trudy, Vsesoyuznyi Nauchno-Issledovatel'skii Institut
Zerna i Produktov Ego Pererabotki. [Transactions, Ail-Union Scientific Research Institute of Grain and
Grain Products.] (33):37-54.
05019407 Kohno, M.; Matsuo, T.; Yamaguchi, Y.; Saito, R.; Sato, K.; Tomaru, K. (1974) Rinka aruminiumu
kunjozai ni yoru chozo tabako gaichu bojo ni kansuru kenkyu (dai san ho) Atarashii zaikei no rinka
aruminiumu kunjozai no jitsuyo shiken [Studies on the fumigant effects of aluminum phosphide against
stored-tobacco insects Report III An application test of a new type of aluminum phosphide fumigant
[Nippon Sembai Kosha Chuo Kenkyusho Kenkyu Hokoku. [Scientific Papers of Central Research
Institute, Japan Monopoly Corporation.] (116):35-42.
05020467 Dumas, T. (1980) Phosphine sorption and desorption by stored wheat and corn. Journal of Agricultural
and Food Chemistry 28(2):337-339.
05020562 Leesch, J.G; Gillenwater, H.B.; Davis, R.; Wilson, R., Jr. (1979) Phosphine and methyl bromide
fumigation of shelled peanuts. Peanut Science 6(1): 18-26.
05022032 Kavadia, V.S.; Chandrasekaran, K.N.; Sharma, N. (1979) Extent of phosphine residues in cereals and
cereal products. Pages 77-77, In Proceedings of the 1st Indian Convention of Food Scientists and
Technologists; Jun 23-24, 1978, Mysore, India. Mysore, India: Association of Food Scientists and
Technologists.
40418701 De Mello Pinta, E.; Bajer, W. (1987) Aluminum Phosphide/Phosphine Product Specific Data Report:
Laboratory Project ID: Project Delta—1986. Unpublished compilation prepared by Casa Bernardo' s
Ltda. 72 p.
40607901 Midland Fumigant, Inc. (1987) Aluminum Phosphide: [Product Chemistry Data]. Unpublished study.
28 p.
142
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BIBLIOGRAPHY
MRID
CITATION
40610401 Schwarz, R. (1988) Aluminum Phosphide: Complete Data Submission for the Active Ingredient
Aluminum Phosphide. Unpublished compilation prepared by Phos-Fume Chemical Co., Inc. 24 p.
40717201 Mansdorf, S.; Knupp, T.; Bold, M. (1988) Phosphine Exposure Monitoring for Applicators, Workers,
and Nearby Persons. Unpublished study prepared by S.Z. Mansdorf & Associates. 1180 p.
40954901 Subramanian, K. (1988) Aluminium Phosphide (Quikfume): Product Chemistry: Project ID:
UPL:EPA:ALP: 1:88. Unpublished study prepared by United Phosphorus Ltd. 11 p.
40954902 Subramanian, K. (1988) Product Chemistry on Quikfume: Project ID: UPL:EPA:ALP: 1988.
Unpublished study prepared by United Phosphorus Ltd. 12 p.
40954903 Subramanian, K. (1988) Product Chemistry on Quikfume: Project ID: UPL:EPA:ALP: 1:88.
Unpublished study prepared by United Phosphorus Ltd. 7 p.
41377001 Newton, P. (1989) An Acute Inhalation Toxicity Study of Phosphine (PH3) in the Rat: Final Report: Lab
Project Number: 87/8029. Unpublished study prepared by Bio/dynamics Inc. 190 p.
41377002 Schroeder, R. (1989) An Inhalation Developmental Toxicity Study of Phosphine (PH3) in Rats: Lab
Project Number: 89/3413. Unpu- blished study prepared by Bio/dynamics, Inc. 470 p.
41413101 Newton, P. (1990) A Thirteen Week Inhalation Toxicity Study of Phosphine (PH3) in the Rat: Final
Report: Project No. 87-8030. Unpublished study prepared by Bio/dynamics, Inc. 1268 p.
41421201 Shaheen, D. (1984) Degesch Aluminum Phosphide: Products Chemistry. Unpublished study. 42 p.
41421202 Shaheen, D. (1984) Degesch Magnesium Phosphide: Products Chemistry. Unpublished study. 53 p.
41434301 Stankowski, L. (1990) Ames/Salmonella Plate Incorporation Assay on Hydrogen Phosphide (PH3): Lab
Project Number: PH/301-DA-001-89. Unpublished study prepared by Pharmakon Research International,
Inc. 128 p.
41434302 SanSebastian, J. (1990) Structural Chromosome Aberration: Chinese Hamster Ovary (CHO) Cell
Induced by Hydrogen Phosphide (PH3): Lab Project Number: PH 320-DA-001-89. Unpublished study
pre- pared by Pharmakon Research International, Inc. 457 p.
41692102 Subramanian, K. (1989) Product Chemistry on Magnaphos: Physical and Chemical Characteristics: Lab
Project Number: UPL: EPA: MGP: 89. Unpublished study prepared by R & D Laboratory/United
Phosphorus Ltd. Factory. 7 p.
41723901 Moog, A. (1990) Aluminium Phosphide: Beginning Materials and Manufacturing Process, Discussion of
Impurities: Lab Project Number: STUDY 1. Unpublished study prepared by Detia Freberg GMBH.
5p.
143
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BIBLIOGRAPHY
MRID
CITATION
42788101 Chun, 1; Neeper-Bradley, T. (1993) Two-Generation Reproduction Study of Inhaled Ethylene Oxide
Vapor in DC Rats: Lab Project Number: 91N0058. Unpublished study prepared by Bushy Run Research
Center. 572 p.
43024001 Subramanian, K. (1989) Magnesium Phosphide (MAGNAPHOS) Product Chemistry: (Product Identity
and Composition): Lab Project Number: UPL: EPA: MGP: 1: 89. Unpublished study prepared by R&D
Lab, United Phosphorus Ltd. 15 p.
43024002 Subramanian, K. (1989) Product Chemistry on MAGNAPHOS (Magnesium Phosphide) Physical and
Chemical Characteristics: Lab Project Number: UPL: EPA: MGP: 89. Unpublished study prepared by
R&D Lab, United Phosphorus Ltd. 7 p.
43315101 Kligerman, A.; Bishop, J.; Erexson, G.; et al. (1994) Cytogenetic and Germ Cell Effects of Phosphine
Inhalation by Rodents II: Subacute Exposures to Rats and Mice. Unpublished study prepared by
National Institute of Environmental Health Science Inhalation Facility, US EPA. 28 p.
43315102 Barbosa, A.; Rosinova, E.; Dempsey, J.; et al. (1994) Determination of Genotoxic and Other Effects in
Mice Following Short Term Repeated-Dose and Subchronic Inhalation Exposure to Phosphine.
Unpublished study prepared by National Institute of Occupational Health and Safety and CSIRO
(Australia) and FHDF, Dept. of Occupational Health (Brazil). 25 p.
43315103 Kligerman, A.; Bryant, M.; Doers, C.; et al. (1994) Cytogenetic effects of phosphine inhalation by
rodents. I: Acute 6-hour exposure of mice. Environmental and Molecular Mutagenesis 23:186-189.
44139001 Schaefer, G. (1996) Acute Neurotoxicity Study in Rats: Phosphine: Lab Project Number: 750-002:
11856: 11851. Unpublished study prepared by MPI Research. 518 p.
44210401 Schaefer, G. (1997) A 90-Day Inhalation Neurotoxicity Study of Phosphine in Rats: Lab Project
Number: 750-003: 182-006. Unpublished study prepared by MPI Research and Experimental Pathology
Labs, Inc. 822 p.
44415101 Newton, P. (1997) 2-Year Combined Inhalation Chronic Toxicity and Oncogenicity Study of Phosphine
in Rats (52-Week Interim Sacrifice Report): Lab Project Number: 750-001: 750-001 (INTERIM).
Unpublished study prepared by MPI Research. 615 p.
44608702 Shaheen, D. (1993) Degesch Magnesium Phosphide Products Chemistry: MRID 41421202. Unpublished
study prepared by Degesch America, Inc. 67 p.
144
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Other References
ACGIH Publication 0206. Documentation of the Threshold Limit Values and Biological Exposure Indices, 6th Ed.
Allen, James R. 1993. How are Pesticides Containing Aluminum or Magnesium Phosphide Used? Research Products
Company.
Baker, R. 1992. Exposure of Persons to Phosphine Gas from Aluminum Phosphide Application to Rodent Burrows.
California State Polytechnic University.
Berck, B. And F.A. Gunther. 1970. Rapid Determination of Sorption Affinity of Phosphine by Fumigation within a Gas
Chromatographic Column. J. Agric. FoodChem. 18(1): 148-153.
Cotton, F.A. and G. Wilkerson. 1988. Advanced Inorganic Chemistry. Fifth Edition. John Wiley and Sons, New
York.
Eiseman, F., Glindemann, D., Bergman, A., and P. Kuschk. 1997. Soils and a Source and Sink of Phosphine.
Chemoshpere 35(3): 523-533.
Environmental Fate and Effects Division. Phosphine EFED One-Liner, 1998.
Fluck, E. The Chemistry of Phosphine. 1973. in Topics in Current Chemistry. 35:1-64.
Garry, V.F., Good, P.F., Manivel, J.C., and D.P. Pearl. 1993. Investigation of a Fatality from Nonoccupational
Aluminum Phosphide Exposure: Measurements of Aluminum in Tissues and Body Fluids as a Marker of Exposure.
Journal of Laboratory and Clinical Medicine 122. 73 9-747.
Greenwood, N.N. and A. Earnshaw. 1984. Chemistry of the Elements. Pergamon Press, Oxford, U.K.
Hackenberg, U. 1972. Chronic ingestion by rats of standard diet treated with aluminum phosphide. Toxicol. Appl.
Pharmacol. 23:147-158.
Hilton, H.W. and W.H. Robinson. 1972. Fate of Zinc Phosphide and Phosphine in the Soil-Water Environment. J.
Agric. Food Chem. 20(6): 1209-1213.
Jones, A.T., Jones, R.C., Longley, E.O. 1962. unpublished report. New South Wales, Division of Occupational Health.
Leesch, J.G. et al. 1995. Practical Fumigation Considerations.
Lindsay, W.L. 1979 Chemical Equilibria in Soils. John Wiley and Sons, New York.
NIOSH, Zaebst, A., et. al. 1987.
U.S. EPA. 1998. S. Gross. Aluminum/Magnesium Phosphide RED - Toxicology Chapter. PC Code: 066501, DP
Barcode D237177. April 30, 1998.
U.S. EPA. 1998. Chemistry Science Advisory Council. Aluminum and Magnesium Phosphide: Food Use vs. Nonfood
Us. June 9, 1998.
145
-------
U.S. EPA. 1998. S. Gross. Aluminum/Magnesium Phosphide - Report of the Hazard Identification Assessment Review
Committee.
U.S. EPA. 1998. D. Hrdy. Aluminum and Magnesium Phosphide. Case 0025 and 0645. Chemical No. 066501 and
066504. Product and Residue Chemistry Chapters for the Aluminum Phosphide and Magnesium Phosphide
Reregistration Eligibility Decision. CBRS Nos. 17920. DP Barcode 236017.
U.S. EPA. 1998. T. Keigwin. Revised Occupational Exposure Assessment and Recommendations for the
Reregistration Eligibility Decision Document for Aluminum and Magnesium Phosphide. June 10, 1998.
U.S. EPA. 1998. J. Sylvester, R. Mahler, N. Birchfield, and J. Hetrick. Aluminum Phosphide and Magnesium
Phosphide Reregistration Eligibility Document, DP Barcode: 236730.]
World Health Organization. 1988. Phosphine and Selected Metal Phosphides. WHO, Geneva.
146
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection Agency
(EPA, the Agency). These data are necessary to maintain the continued registration of your
product(s) containing this active ingredient. Within 90 days after you receive this Notice you must
respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 5; or
2. Why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3, Requirements Status and Registrant's Response Form, (see section
III-B); or
3. Why you believe EPA should not require your submission of product specific data
in the manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with
its requirements or should be exempt or excused from doing so, then the registration of your
147
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product(s) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 2, Data Call-In Response Form, as well as a list
of all registrants who were sent this Notice (Attachment 5).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
and 2070-0057 (expiration date 03-31-99).
This Notice is divided into six sections and six Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse
Effects
Section VT - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form (Insert A)
3 - Requirements Status and Registrant's Response Form (Insert B)
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
SECTIONI. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the data
needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional generic
data requirements are being imposed. You have been sent this Notice because you have product(s)
containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3, Requirements
Status and Registrant's Response Form (Insert B). Depending on the results of the studies required in
this Notice, additional testing may be required.
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II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in Insert B,
Requirements Status and Registrant's Response Form (Insert BX within the time frames provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have
been established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-605-6000).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those
specified in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the
OECD protocols, they should be modified as appropriate so that the data generated by the
study will satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend
deadlines for complying with data requirements when the studies were not conducted in
accordance with acceptable standards. The OECD protocols are available from OECD, 2001
L Street, N.W., Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone
number 202-785-03 50).
All new studies and proposed protocols submitted in response to this Data Call-In
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change
the requirements of any previous Data Call-In(sX or any other agreements entered into with
the Agency pertaining to such prior Notice. Registrants must comply with the requirements of
all Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data
must be submitted to the Agency within 90 days after your receipt of this Notice. Failure to
adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a
Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance
of NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B.
149
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III-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice
or (c) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product
specific data requirements of this Notice is contained in Section III-C. A discussion of
options relating to requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are the Data-
Call-in Response Form (Insert A), and the Requirements Status and Registrant's Response
Form (Insert B). The Data Call-In Response Form must be submitted as part of every response
to this Notice. In addition, one copy of the Requirements Status and Registrant's Response
Form (Insert B) must be submitted for each product listed on the Data Call-In Response Form
(Insert A) unless the voluntary cancellation option is selected or unless the product is
identical to another (refer to the instructions for completing the Data Call-In Response
Form(Insert A). Please note that the company's authorized representative is required to sign
the first page of the Data Call-In Response Form (Insert A) and Requirements Status and
Registrant's Response Form (Insert B), initial any subsequent pages. The forms contain
separate detailed instructions on the response options. Do not alter the printed material. If
you have questions or need assistance in preparing your response, call or write the contact
person(s) identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by
requesting voluntary cancellation of your product(s) containing the active ingredient that is
the subject of this Notice. If you wish to voluntarily cancel your product, you must submit a
completed Data Call-In Response Form (Insert AX indicating your election of this option.
Voluntary cancellation is item number 5 on the Data Call-In Response Form (Insert B). If you
choose this option, this is the only form that you are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These
options are discussed in Section III-C of this Notice and comprise options 1 through 5 on the
Requirements Status and Registrant's Response Formdnsert A) and item numbers 7a and 7b
on the Data Call-In Response Formdnsert B). Deletion of a use(s) and the low volume/minor
use option are not valid options for fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements
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Status and Registrant's Response Form (Insert B). If you choose one of these options, you
must submit both forms as well as any other information/data pertaining to the option chosen
to address the data requirement.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form (Insert A) that you agree to
satisfy the product specific data requirements (i.e. you select item number 7a or 7b), then you
must select one of the six options on the Requirements Status and Registrant's Response Form
(Insert A) related to data production for each data requirement. Your option selection should
be entered under item number 9, "Registrant Response." The six options related to data
production are the first six options discussed under item 9 in the instructions for completing
the Requirements Status and Registrant's Response Formdnsert A). These six options are
listed immediately below with information in parentheses to guide registrants to additional
instructions provided in this Section. The options are:
(1) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing study
that has been submitted but not reviewed by the Agency (Citing an Existing Study)
Option 1, Developing Data ~ If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced here
in and in the attachments. All data generated and submitted must comply with the Good
Laboratory Practice (GLP) rule (40 CFRPart 160), be conducted according to the Pesticide
Assessment Guidelines(PAG), and be in conformance with the requirements of PR Notice 86-
5.
The time frames in the Requirements Status and Registrant's Response Form (Insert A)
are the time frames that the Agency is allowing for the submission of completed study reports.
The noted deadlines run from the date of the receipt of this Notice by the registrant. If the
data are not submitted by the deadline, each registrant is subject to receipt of a Notice of
Intent to Suspend the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to
the Agency which includes: (1) a detailed description of the expected difficulty and (2) a
proposed schedule including alternative dates for meeting such requirements on a step-by-step
basis. You must explain any technical or laboratory difficulties and provide documentation
from the laboratory performing the testing. While EPA is considering your request, the
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original deadline remains. The Agency will respond to your request in writing. If EPA does
not grant your request, the original deadline remains. Normally, extensions can be requested
only in cases of extraordinary testing problems beyond the expectation or control of the
registrant. Extensions will not be given in submitting the 90-day responses. Extensions will
not be considered if the request for extension is not made in a timely fashion; in no event shall
an extension request be considered if it is submitted at or after the lapse of the subject
deadline.
Option 2, Agreement to Share in Cost to Develop Data ~ Registrants may only choose this
option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the
products in the group. The registration number of the product for which data will be
submitted must be noted in the agreement to cost share by the registrant selecting this option.
If you choose to enter into an agreement to share in the cost of producing the required data but
will not be submitting the data yourself, you must provide the name of the registrant who will
be submitting the data. You must also provide EPA with documentary evidence that an
agreement has been formed. Such evidence may be your letter offering to join in an
agreement and the other registrant's acceptance of your offer, or a written statement by the
parties that an agreement exists. The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or the mechanism to resolve the terms.
Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the agreement they
may resolve their differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development ~ This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an
offer to pay in an attempt to enter into an agreement or amend an existing agreement to meet
the requirements of this Notice and have been unsuccessful, you may request EPA (by
selecting this option) to exercise its discretion not to suspend your registration(s), although
you do not comply with the data submission requirements of this Notice. EPA has determined
that as a general policy, absent other relevant considerations, it will not suspend the
registration of a product of a registrant who has in good faith sought and continues to seek to
enter into a joint data development/cost sharing program, but the other registrant(s)
developing the data has refused to accept your offer. To qualify for this option, you must
submit documentation to the Agency proving that you have made an offer to another registrant
(who has an obligation to submit data) to share in the burden of developing that data. You
must also submit to the Agency a completed EPA Form 8570-32, Certification of Offer to
Cost Share in the Development of Data, Attachment 7. In addition, you must demonstrate that
the other registrant to whom the offer was made has not accepted your offer to enter into a
cost sharing agreement by including a copy of your offer and proof of the other registrant's
receipt of that offer (such as a certified mail receipt). Your offer must, in addition to anything
else, offer to share in the burden of producing the data upon terms to be agreed or failing
agreement to be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii)
and must not qualify this offer. The other registrant must also inform EPA of its election of
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an option to develop and submit the data required by this Notice by submitting a Data Call-In
Response Form (Insert A) and a Requirements Status and Registrant's Response Form (Insert
B) committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your
offer to share in the burdens of developing the data. In addition, the other registrant must
fulfill its commitment to develop and submit the data as required by this Notice. If the other
registrant fails to develop the data or for some other reason is subject to suspension, your
registration as well as that of the other registrant will normally be subject to initiation of
suspension proceedings, unless you commit to submit, and do submit the required data in the
specified time frame. In such cases, the Agency generally will not grant a time extension for
submitting the data.
Option 4, Submitting an Existing Study ~ If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed
by this Notice. You may only submit a study that has not been previously submitted to the
Agency or previously cited by anyone. Existing studies are studies which predate issuance of
this Notice. Do not use this option if you are submitting data to upgrade a study. (See Option
5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid
and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of
the following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data and
specimens from the study are available for audit and review and you must identify
where they are available. This must be done in accordance with the requirements of
the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in 40 CFR
160.3(j)" 'raw data' means any laboratory worksheets, records, memoranda, notes, or
exact copies thereof, that are the result of original observations and activities of a
study and are necessary for the reconstruction and evaluation of the report of that
study. In the event that exact transcripts of raw data have been prepared (e.g., tapes
which have been transcribed verbatim, dated, and verified accurate by signature), the
exact copy or exact transcript may be substituted for the original source as raw data.
'Raw data' may include photographs, microfilm or microfiche copies, computer
printouts, magnetic media, including dictated observations, and recorded data from
automated instruments." The term "specimens", according to 40 CFR 160.3(k), means
"any material derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
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submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study signed
by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the Pesticide
Assessment Guidelines (PAG) or meets the purpose of the PAG (both available from
NTIS). A study not conducted according to the PAG may be submitted to the Agency
for consideration if the registrant believes that the study clearly meets the purpose of
the PAG. The registrant is referred to 40 CFR 158.70 which states the Agency's policy
regarding acceptable protocols. If you wish to submit the study, you must, in addition
to certifying that the purposes of the PAG are met by the study, clearly articulate the
rationale why you believe the study meets the purpose of the PAG, including copies of
any supporting information or data. It has been the Agency's experience that studies
completed prior to January 1970 rarely satisfied the purpose of the PAG and that
necessary raw data are usually not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements
of the criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not
meet the criteria outlined above but does contain factual information regarding unreasonable
adverse effects, you must notify the Agency of such a study. If such study is in the Agency's
files, you need only cite it along with the notification. If not in the Agency's files, you must
submit a summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study ~ If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement
is not satisfied, you may still be required to submit new data normally without any time
extension. Deficient, but upgradeable studies will normally be classified as supplemental.
However, it is important to note that not all studies classified as supplemental are
upgradeable. If you have questions regarding the classification of a study or whether a study
may be upgraded, call or write the contact person listed in Attachment 1. If you submit data to
upgrade an existing study you must satisfy or supply information to correct all deficiencies in
the study identified by EPA. You must provide a clearly articulated rationale of how the
deficiencies have been remedied or corrected and why the study should be rated as acceptable
to EPA. Your submission must also specify the MRID number(s) of the study which you are
attempting to upgrade and must be in conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
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This option should also be used to cite data that has been previously submitted to
upgrade a study, but has not yet been reviewed by the Agency. You must provide the MRID
number of the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to
all data submissions intended to upgrade studies. Additionally your submission of data
intended to upgrade studies must be accompanied by a certification that you comply with each
of those criteria as well as a certification regarding protocol compliance with Agency
requirements.
Option 6, Citing Existing Studies ~ If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it
must be a study which has not yet been reviewed by the Agency. Acceptable toxicology
studies generally will have been classified as "core-guideline" or "core minimum." For all
other disciplines the classification would be "acceptable." With respect to any studies for
which you wish to select this option you must provide the MRID number of the study you are
citing and, if the study has been reviewed by the Agency, you must provide the Agency's
classification of the study.
If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form 8570-34, Certification with Respect to Citations of
Data (in PR Notice 98-51.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-In Response Form (Insert A) and
the Requirements Status and Registrant's Response Form (Insert B), as appropriate.
III-D. REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. (Note: any
supplemental data must be submitted in the format required by PR Notice 86-5). This will be
the only opportunity to state the reasons or provide information in support of your request. If
the Agency approves your waiver request, you will not be required to supply the data pursuant
to section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an
option for meeting the data requirements of this Notice within 30 days of the receipt of the
Agency's decision. You must indicate and submit the option chosen on the Requirements
Status and Registrant's Response Form. Product specific data requirements for product
chemistry, acute toxicity and efficacy (where appropriate) are required for all products and the
Agency would grant a waiver only under extraordinary circumstances. You should also be
aware that submitting a waiver request will not automatically extend the due date for the study
in question. Waiver requests submitted without adequate supporting rationale will be denied
and the original due date will remain in force.
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IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice
due to failure by a registrant to comply with the requirements of this Data Call-In Notice,
pursuant to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice
of Intent to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study as
required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task Forces,
failure to comply with the terms of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted studies,
as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or failure of
a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this Notice on
a Data Call-In Response Formdnsert A) and a Requirements Status and
Registrant's Response Formdnsert B):
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this Notice,
unless you commit to submit and do submit the required data in the specified
time frame.
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9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The
grounds for suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents incorporated by
reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data Reporting
Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design, conduct, and
reporting of required studies. Such requirements include, but are not limited to, those relating
to test material, test procedures, selection of species, number of animals, sex and distribution
of animals, dose and effect levels to be tested or attained, duration of test, and, as applicable,
Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation of
any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting, the
completeness of results, and the adequacy of any required supporting (or raw) data, including,
but not limited to, requirements referenced or included in this Notice or contained in PR 86-5.
All studies must be submitted in the form of a final report; a preliminary report will not be
considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or canceled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally
not be consistent with the Act's purposes. Accordingly, the Agency anticipates granting
registrants permission to sell, distribute, or use existing stocks of suspended product(s) only in
exceptional circumstances. If you believe such disposition of existing stocks of your
product(s) which may be suspended for failure to comply with this Notice should be
permitted, you have the burden of clearly demonstrating to EPA that granting such permission
would be consistent with the Act. You must also explain why an "existing stocks" provision is
necessary, including a statement of the quantity of existing stocks and your estimate of the
time required for their sale, distribution, and use. Unless you meet this burden the Agency
will not consider any request pertaining to the continued sale, distribution, or use of your
existing stocks after suspension.
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If you request a voluntary cancellation of your product(s) as a response to this Notice
and your product is in full compliance with all Agency requirements, you will have, under
most circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use
such existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily canceled products containing an active ingredient for which the Agency has
particular risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required
by this Notice will not result in the Agency granting any additional time to sell, distribute, or
use existing stocks beyond a year from the date the 90 day response was due unless you
demonstrate to the Agency that you are in full compliance with all Agency requirements,
including the requirements of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3 year study is scheduled to be submitted, all progress
reports and other information necessary to establish that you have been conducting the study
in an acceptable and good faith manner must have been submitted to the Agency, before EPA
will consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLEUNREASONABLE
ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a pesticide
is registered a registrant has additional factual information regarding unreasonable adverse effects on
the environment by the pesticide, the registrant shall submit the information to the Agency.
Registrants must notify the Agency of any factual information they have, from whatever source,
including but not limited to interim or preliminary results of studies, regarding unreasonable adverse
effects on man or the environment. This requirement continues as long as the products are registered
by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by
this Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status
Sheet.
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All responses to this Notice (other than voluntary cancellation requests and generic
data exemption claims) must include a completed Data Call-In Response Form (Insert A) and
a completed Requirements Status and Registrant's Response Form (Insert B) for product
specific data) and any other documents required by this Notice, and should be submitted to
the contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-In Response Form (Insert A) need be
submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this
Notice.
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregistration Division
Attachments
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form (Insert A)
3 - Requirements Status and Registrant's Response Form (Insert B)
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data Requirements
for Reregistration
5 - List of Registrants Receiving This Notice
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ALUMINUM AND MAGNESIUM PHOSPHIDE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing Aluminum and Magnesium Phosphide.
This Product Specific Data Call-In Chemical Status Sheet contains an overview of data required
by this notice, and point of contact for inquiries pertaining to the reregi strati on of Aluminum and
Magnesium Phosphide. This attachment is to be used in conjunction with (1) the Product Specific Data
Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use Products
for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA Acceptance Criteria
(Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6) and (7) the Cost Share and
Data Compensation Forms in replying to this Aluminum and Magnesium Phosphide Product Specific
Data Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for Aluminum and Magnesium
Phosphide are contained in the Requirements Status and Registrant's Response. Attachment 3. The
Agency has concluded that additional data on Aluminum and Magnesium Phosphide are needed for
specific products. These data are required to be submitted to the Agency within the time frame listed.
These data are needed to fully complete the reregi strati on of all eligible Aluminum and Magnesium
Phosphide products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding this product specific data requirements and procedures
established by this Notice, please contact Bonnie Adler at (703) 308-8523.
All responses to this Notice for the Product Specific data requirements should be submitted to:
Bonnie Adler
Chemical Review Manager Team 81
Product Reregi strati on Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Aluminum and Magnesium Phosphide
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose this option,
you will not have to provide the data required by the Data Call-In Notice and you will
not have to complete any other forms. Further sale and distribution of your product after
the effective date of cancellation must be in accordance with the Existing Stocks
provision of the Data Call-In Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you must
respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the EPA
registration numbers of your source(s); you would not complete the "Requirements
Status and Registrant's Response" form. Examples of such products include repackaged
products and Special Local Needs (Section 24c) products which are identical to
federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you must
agree to satisfy the data requirements by responding "yes." If you are requesting a data
waiver, answer "yes" here; in addition, on the "Requirements Status and Registrant's
Response" form under Item 9, you must respond with Option 7 (Waiver Request) for
each study for which you are requesting a waiver. See Item 6 with regard to identical
products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed letter
that accompanies this form. For example, you may wish to report that your product has
already been transferred to another company or that you have already voluntarily
canceled this product. For these cases, please supply all relevant details so that EPA can
ensure that its records are correct.
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This page has been inserted as a place marker and is replaced by an electronically generated PDCI
sample Part A form page number 1 in the actual Printed version of the Red document
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in Item 3.
This number must be used in the transmittal document for any data submissions in
response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to support the product's continued
registration are identified. These guidelines, in addition to the requirements specified in
the Notice, govern the conduct of the required studies. Note that series 61 and 62 in
product chemistry are now listed under 40 CFR 158.155 through 158.180, Subpart C.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific requirements is
(are) identified. For most product specific data requirements, all use patterns are covered
by the data requirements. In the case of efficacy data, the required studies only pertain
to products which have the use sites and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the product
as formulated for sale and distribution is the test substance, except in rare cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8 months
after issuance of the Reregistration Eligibility Document unless EPA determines that
a longer time period is necessary.
Item 9 Enter only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data). By
indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in the
Data Call-In Notice. By the specified due date, I will also submit: (1) a completed
"Certification with Respect to Citations of Data (in PR Notice 98-5)" form (EPA
Form 8570-34) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4)
2. I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing). I am submitting a copy of this agreement. I understand that this
option is available only for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this Notice that my product is similar enough to another
product to qualify for this option. I certify that another party in the agreement is
committing to submit or provide the required data; if the required study is not submitted
on time, my product may be subject to suspension. By the specified due date, I will also
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submit: (1) a completed "Certification with Respect to Citations of Data (in PR
Notice 98-5)" form (EPA Form 8570-34) and (2) two completed and signed copies of
the Confidential Statement of Formula (EPA Form 8570-4)
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy data and
only if EPA indicates in an attachment to this Data Call-In Notice that my product is
similar enough to another product to qualify for this option. I am submitting evidence
that I have made an offer to another registrant (who has an obligation to submit data)
to share in the cost of that data. I am also submitting a completed "Certification of
Attempt to Enter into an Agreement with other Restraints for Development of
Data " (EPA Form 8570-32). I am including a copy of my offer and proof of the other
registrant's receipt of that offer. I am identifying the party which is committing to submit
or provide the required data; if the required study is not submitted on time, my product
may be subject to suspension. I understand that other terms under Option 3 in the Data
Call-In Notice (Section III-C.l.) apply as well. By the specified due date, I will also
submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-34) and (2) two completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4)
4. By the specified due date, I will submit an existing study that has not been submitted
previously to the Agency by anyone (Submitting an Existing Study). I certify that this
study will meet all the requirements for submittal of existing data outlined in Option 4
in the Data Call-In Notice (Section III-C.l.) and will meet the attached acceptance
criteria (for acute toxicity and product chemistry data). I will attach the needed
supporting information along with this response. I also certify that I have determined
that this study will fill the data requirement for which I have indicated this choice. By
the specified due date, I will also submit a completed "Certification With Respect To
Data Compensation Requirements" form (EPA Form 8570-34) to show what data
compensation option I have chosen. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-34) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4)
5. By the specified due date, I will submit or cite data to upgrade a study classified by the
Agency as partially acceptable and upgradable (Upgrading a Study). I will submit
evidence of the Agency's review indicating that the study may be upgraded and what
information is required to do so. I will provide the MRID or Accession number of the
study at the due date. I understand that the conditions for this option outlined Option
5 in the Data Call-In Notice (Section III-C.l.) apply. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-34) and (2) two completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4)
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6. By the specified due date, I will cite an existing study that the Agency has classified as
acceptable or an existing study that has been submitted but not reviewed by the Agency
(Citing an Existing Study). If I am citing another registrant's study, I understand that
this option is available only for acute toxicity or certain efficacy data and only if the cited
study was conducted on my product, an identical product or a product which EPA has
"grouped" with one or more other products for purposes of depending on the same data.
I may also choose this option if I am citing my own data. In either case, I will provide
the MRID or Accession number(s) for the cited data on a "Product Specific Data
Report" form or in a similar format. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-34) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4)
7. I request a waiver for this study because it is inappropriate for my product (Waiver
Request). I am attaching a complete justification for this request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. [Note:
any supplemental data must be submitted in the format required by P.R. Notice 86-5].
I understand that this is my only opportunity to state the reasons or provide information
in support of my request. If the Agency approves my waiver request, I will not be
required to supply the data pursuant to Section 3(c)(2)(B) of FIFRA. If the Agency
denies my waiver request, I must choose a method of meeting the data requirements of
this Notice by the due date stated by this Notice. In this case, I must, within 30 days of
my receipt of the Agency's written decision, submit a revised "Requirements Status and
Registrant's Response" Form indicating the option chosen. I also understand that the
deadline for submission of data as specified by the original data call-in notice will not
change. By the specified due date, I will also submit: (1) a completed "Certification
With Respect To Data Compensation Requirements" form (EPA Form 8570-34)
and (2) two completed and signed copies of the Confidential Statement of Formula
(EPA Form 8570-4)
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a signed letter
that accompanies this form. For example, you may wish to report that your product has
already been transferred to another company or that you have already voluntarily
canceled this product. For these cases, please supply all relevant details so that EPA can
ensure that its records are correct.
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EPA'S BATCHING OF Aluminum/Magnesium Phosphide PRODUCTS FOR MEETING ACUTE
TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregi strati on of products containing Aluminum/Magnesium Phosphide
as the active ingredient, the Agency has batched products which can be considered similar for purposes
of acute toxicity. Factors considered in the sorting process include each product's active and inert
ingredients (identity, percent composition and biological activity), type of formulation (e.g., emulsifiable
concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word, use classification,
precautionary labeling, etc.). Note that the Agency is not describing batched products as "substantially
similar" since some products within a batch may not be considered chemically similar or have identical
use patterns.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwith-standing the batching process, the Agency reserves the right to require,
at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a
single battery of six acute toxicological studies to represent all the products within that batch. It is the
registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the required acute toxicological
studies for each of their own products. If a registrant chooses to generate the data for a batch, he/she
must use one of the products within the batch as the test material. If a registrant chooses to rely upon
previously submitted acute toxicity data, he/she may do so provided that the data base is complete and
valid by today's standards (see acceptance criteria attached), the formulation tested is considered by EPA
to be similar for acute toxicity, and the formulation has not been significantly altered since submission
and acceptance of the acute toxicity data. Regardless of whether new data is generated or existing data
is referenced, registrants must clearly identify the test material by EPA Registration Number. If more
than one confidential statement of formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI Notice
contains two response forms which are to be completed and submitted to the Agency within 90 days of
receipt. The first form, "Data Call-In Response," asks whether the registrant will meet the data
requirements for each product. The second form, "Requirements Status and Registrant's Response," lists
the product specific data required for each product, including the standard six acute toxicity tests. A
registrant who wishes to participate in a batch must decide whether he/she will provide the data or
depend on someone else to do so. If a registrant supplies the data to support a batch of products, he/she
must select one of the following options: Developing Data (Option 1), Submitting an Existing Study
(Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6). If a
registrant depends on another's data, he/she must choose among: Cost Sharing (Option 2), Offers to
Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant does not want to participate
in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not
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to participate in a batch does not preclude other registrants in the batch from citing his/her studies and
offering to cost share (Option 3) those studies.
The following products contain Aluminum Phosphide as the active ingredient.
Twenty four products contain aluminum phosphide as the active ingredient. They are separated into five
batches, based on the percentages and compositions of the active and the inert ingredients, there are no
acute toxicity data provided by the registrants. Two products were considered to be not similar and were
not placed in any batch. The registrants of these products are responsible for meeting the acute toxicity
data requirements separately. Each product, however, may rely on acute data performed with the
technical, or request waivers based on the highly toxic nature of these materials.
Table 1.
Batch
1
EPA Reg. No.
30574-1
30574-4
30574-9
30574-10
30574-11
% Active Ingredient
60
60
60
60
60
Formulation Type
solid
solid
solid
solid
solid
Batch
2
EPA Reg. No.
59209-1
59209-2
59209-3
% Active Ingredient
60
60
60
Formulation Type
solid
solid
solid
Batch
3
EPA Reg. No.
43743-1
43743-2
43743-3
30574-5
30574-6
% Active Ingredient
57
57
57
57
57
Formulation Type
solid
solid
solid
solid
solid
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Batch
EPA Reg. No.
30574-7
30574-8
% Active Ingredient
57
57
Formulation Type
solid
solid
Batch
4
EPA Reg. No.
5857-1
5857-2
5857-6
% Active Ingredient
55
55
55
Formulation Type
solid
solid
solid
Batch
5
EPA Reg. No.
40285-1
40285-3
40285-13
40285-14
% Active Ingredient
55
55
55
55
Formulation Type
solid
solid
solid
solid
Table 2 (No Batch).
EPA Reg. No.
59209-8
40285-16
% Active Ingredient
57
57
Formulation Type
solid
solid
The following products contain Magnesium Phosphide as the active ingredient.
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Four products contain magnesium phosphide as the active ingredient. Two of them are grouped into one
batch,in accordance with the percentages and compositions of the active and the inert ingredients, and
type of formulation. The other two products were considered to be not similar and were not placed in
any batch. The registrants of these products are responsible for meeting the acute toxicity data
requirements separately. Each product, however, may rely on acute data performed with the technical.
TableS.
No
Batch
6
EPA Reg. No.
59209-4
59209-6
% Active Ingredient
66
66
Formulation Type
solid
solid
Table 4 (No Batch).
EPA Reg. No.
40285-12
40285-8
% Active Ingredient
66
56
Formulation Type
solid
solid
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List of Registrants page number 1 in the actual Printed version of the Red document
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Pesticide Registration Forms are available at the following EPA internet site:
http ://www. epa. gov/opprdOO I/forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled out on
your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the existing policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the address below for the Document Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information'
or 'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-5551
or by e-mail atwilliams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the internet:
at the following locations:
8570-1
8570-4
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide
Registration/Amendment
Confidential Statement of Formula
Certification of Attempt to Enter into an
Agreement with other Restraints for
Development of Data
Certification with Respect to Citations of Data
(in PR Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical Properties
(in PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (in PR Notice
98-1)
http://www.epa.gov/opprd001/forms/8570-l.pdf.
http://www.epa.gov/opprd001/forms/8570-4.pdf.
http://www.epa.gov/opprd001/forms/8570-32.pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-5.pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-5.pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-l .pdf.
http://www.epa.gov/opppmsdl/PR Notices/pr98-l .pdf.
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Pesticide Registration Kit www.epa.gov/pesticides/registrationkit/.
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the following
pertinent forms and information needed to register a pesticide product with the U.S. Environmental
Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug
and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems
(Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This document is
in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format and will
require the Acrobat
reader.)
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require the
Acrobat reader.)
a. Registration Division Personnel Contact List
Biopesticides and Pollution Prevention Division (BPPD) Contacts
Antimicrobials Division Organizational Structure/Contact List
c. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements (PDF
format)
d. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format)
e. 40 CFR Part 158, Data Requirements for Registration (PDF format)
f. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
Before submitting your application for registration, you may wish to consult some additional sources
of information.
These include:
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1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in the United
States", PB92-221811, available through the National Technical Information Service (NTIS)
the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in the
process of updating this booklet to reflect the changes in the registration program resulting from the
passage of the FQPA and the reorganization of the Office of Pesticide Programs. We anticipate that this
publication will become available during the Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center for
Environmental and Regulatory Information Systems. This service does charge a fee for
subscriptions and custom searches. You can contact NPIRS by telephone at (765) 494-6614 or
through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide information on active
ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by telephone
at 1-800-858-7378 or through their Web site.
The Agency will return a notice of receipt of an application for registration or amended registration,
experimental use permit, or amendment to a petition if the applicant or petitioner encloses with his
submission a stamped, self-addressed postcard. The postcard must contain the following entries to be
completed by OPP:
Date of receipt
EPA identifying number
the Product Manager assignment
Other identifying information may be included by the applicant to link the acknowledgment of receipt
to the specific application submitted. EPA will stamp the date of receipt and provide the EPA identifying
File Symbol or petition number for the new submission. The identifying number should be used
whenever you contact the Agency concerning an application for registration, experimental use permit,
or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded and
assigned to your company, please include a list of all synonyms, common and trade names, company
experimental codes, and other names which identify the chemical (including "blind" codes used when
a sample was submitted for testing by commercial or academic facilities). Please provide a CAS number
if one has been assigned.
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Documents Associated with this RED
Electronic File format: Portable Document Format (.PDF) requires Adobe® Acrobat or
compatible reader. Electronic copies of this RED are available
on our web site at www.epa.gov/REDs. or contact Mark Hartman
at (703) 308-0734.
The following documents are part of the Administrative Record for this RED document and may
included in the EPA's Office of Pesticide Programs Public Docket. Copies of these documents are not
available electronically, but may be obtained by contacting the person listed on the respective Chemical
Status Sheet.
1. Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may be obtained
by contacting the person listed on the Chemical Status Sheet of this RED document.
1. The Label Review Manual
2. EPA Acceptance Criteria
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182
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
December 18, 1996
OFFICE OF
PREVENTION, PESTICIDES AND
TOXIC SUBSTANCES
MEMORANDUM
SUBJECT: Review of aluminum phosphide Incident Reports
(DP Barcode D231933, PC Code 066501)
TO: William J. Hazel, Section Head
Special Review Section
Risk Characterization and Analysis Branch (7509C)
and
Jack Housenger, Branch Chief
Special Review Branch
Special Review and Reregi strati on Branch (7508W)
FROM: Jerome Blondell, Ph.D., Health Statistician
Special Review and Registration Section
Occupational and Residential Exposure Branch
Health Effects Division (7509C)
Monica Spann, Environmental Protection Specialist
Special Review and Registration Division (7508W)
THRU: Dick Griffith, Acting Section Head
Special Review and Registration Section
Occupational and Residential Exposure Branch
Health Effects Division (7509C)
Ed Zager, Acting Branch Chief
Occupational and Residential Exposure Branch
Health Effects Division (7509C)
BACKGROUND
The following data bases have been searched for the poisoning incident data on the active ingredient
aluminum phosphide (Case Number: 066501):
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1) OPP IncidentData System (IDS) - reports of incidents from various sources, including registrants,
other federal and state health and environmental agencies and individual consumers, submitted to OPP
since 1992.
2) Poison Control Centers - as the result of Data-Call-ins issued in 1993, OPP received Poison
Control Center data covering the years 1985 through 1992 for 28 organophosphate and carbamate
chemicals. Most of the national Poison Control Centers (PCCs) participate in a national data
collection system, the Toxic Exposure Surveillance System which obtains data from 70 centers at
hospitals or universities. PCCs provide telephone consultation for individuals and health care
providers on suspected poisonings, involving drugs, household products, pesticides, etc.
3) California Department of Food and Agriculture (replaced by the Department of Pesticide
Regulation in 1991) - California has collected uniform data on suspected pesticide poisonings since
1982. Physicians are required, by statute, to report to their local health officer all occurrences of
illness suspected of being related to exposure to pesticides. The majority of the incidents involve
workers. Information on exposure (worker activity), type of illness (systemic, eye, skin, eye/skin and
respiratory), likelihood of a causal relationship, and number of days off work and in hospital are
provided.
4) National Pesticide Telecommunications Network (NPTN) - NPTN is a toll-free information
service supported by OPP. A ranking of the top 200 active ingredients for which telephone calls were
received during calendar years 1984-1991, inclusive has been prepared. The total number of calls was
tabulated for the categories humans, animals, calls, incidents and others.
ALUMINUM PHOSPHIDE REVIEW
I. IDS
Of six cases reported to the Incident Data System, only three involved accidental exposure
to aluminum phosphide alone. Two other cases involved exposures to several pesticides and one
other case was a suicide reported from Mexico. The three accidental cases are summarized below.
On May 22, 1994, the Washington Post reported the death of a thirty-nine year old woman
stationed in Cairo by the U.S. Department of State. In mid-December, she had submitted a pest
extermination work order to the U.S. Embassy to have moths removed from she and her husband's
government-owned apartment. Moths were found in a closet in the middle bedroom. According to
the Naval Medical Research Unit Report, sixty German-made pesticide tablets of phostoxin were used
by a pest-control operator for the extermination. After the extermination, the research team reported
that the fumigated bedroom was sealed with tape, but the apartment's air ducts were not sealed. The
team determined that the gas circulated through the heating system. After arriving home, the woman
and her husband noticed an odor that persisted for a few days. The morning of December 24, her
husband became ill, and at midnight she also became sick. About 9:00 a.m. the next morning, Lewis
arrived at an infirmary experiencing severe difficulty in breathing, and died at 1:00 p.m.
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A letter submitted from a Union representing railway workers stated that members were
exposed to phostoxin while heating and cutting underframes of railcars. This practice is alledged to
result in health problems, but number of workers affected and symptoms were not reported.
A pesticide incident occurred on November 9, 1994, in Ark City, Kansas, that resulted in the
death of a two year old child and the hospitalization of an additional six family members. Apparently,
phostoxin was acquired illegally by a roofer working on the building where it was allegedly
"improperly stored" and misused by a member of the family to control rats in their own residence.
II.
Poison Control Center Data
Aluminum phosphide was not one of 28 chemicals for which Poison Control Center data were
requested.
III. California Data - 1982 through 1994
Detailed descriptions of 166 cases submitted to the California Pesticide Illness Surveillance
Program (1982-1994) were reviewed. In 162 of these cases, aluminum phosphide was used alone
and was judged to be responsible for the health effects. Only cases with a definite, probable or
possible relationship were reviewed. Aluminum phosphide ranked 15th as a cause of systemic
poisoning in California and 7th as a cause of hospitalization. Twenty-one individuals were
hospitalized between 1982 and 1994. Among agricultural workers, aluminum phosphide is the 7th
most frequent cause of systemic poisoning. Table 1 presents the types of illnesses reported by year.
Table 2 gives the total number of workers that took time off work as a result of their illness and how
many were hospitalized and for how long.
Table 1: Cases Due to Aluminum Phosphide Exposure in California Reported by Type of Illness and
Year, 1982-1994
Year
1982
1983
1984
1985
1986
1987
1988
Illness Type
Systemic
5
14
O
13
6
19
18
Eye
1
1
_
_
_
1
25
Skin
_
1
1
1
_
_
_
Respir.
_
_
_
_
_
_
_
Total
6
16
4
14
6
20
43
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1989
1990
1991
1992
1993
1994
Total
6
12
7
4
8
4
119
_
_
1
_
1
_
30
_
1
_
_
_
_
4
1
1
1
_
4
2
9
7
14
9
4
13
6
162
Table 2: Number of Persons Disabled (taking time off work) or Hospitalized for Indicated Number
of Days after Aluminum Phosphide Expsosure in California, 1982-1994.
One day
Two days
3-5 days
6-10 days
more than 10 days
unknown
Number of Persons Disabled
28
16
7
6
5
33
Number of Persons
Hospitalized
10
11
_
_
_
2
Atotal of 119 persons had systemic illnesses or 73% out of 162 persons. The majority of 30
eye-related cases resulted from two incidents which occurred in 1988 when workers returned to
buildings that had been fumigated over the weekend. A variety of worker activities were associated
with exposure to aluminum phosphide as illustrated in Table 3 below.
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Table 3: Illnesses by Activity Categories for Aluminum Phosphide Exposure in California, 1982-1994
Activity Category
Field fumigation
Tarp fumigation
Chamber fumigation
Other applicator
Coincidental
Drift Exposure
Packing/Processing
Emergency response
Other
Total
Illness Category
Systemic
19
19
12
_
22
4
10
11
22
119
Eye
.
1
1
1
25
1
.
_
1
30
Skin
.
2
1
_
.
_
.
_
1
4
Respir-
atory
1
_
.
_
.
1
.
1
6
9
Total
20
22
14
1
47
6
10
12
30
162
According to the above activity categories, coincidental systemic and coincidental eye
categories were associated with the majority of the exposures. Coincidental cases typically occur
when bystanders are accidently exposed. Out of a total of twenty-two systemic coincidental
exposures, sixteen workers became ill after their almond sorting building was fumigated the previous
day. Symptoms included headache, nausea, vomiting, chills, abdominal cramps, weakness, dizziness,
and difficulty breathing. Out of the twenty-five coincidental eye exposures, fourteen workers
experienced eye irritation after their storage building was fumigated the previous weekend.
Symptoms included red and watery eyes, and nasal secretions. The other eleven workers out of the
twenty-five coincidental eye exposures had re-occurring eye irritations while working in an
almond/pistachio processing plant.
Detailed review of the types of activities associated with incidents suggests a number of
patterns that may be amenable to mitigation through improved label warnings. Improper handling
or disposal of aluminum phosphide tablets has resulted in fires and explosions leading to eight
incidents involving 19 people. Workers responsible for opening fumigated structures or removing
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tarps have been involved in 15 incidents. And application to kill gophers or squirrels have resulted
in 13 incidents of poisoning.
REPORTS OF HUMAN POISONINGS FROM THE LITERATURE
A case was reported when aluminum phosphide tablets were mistakenly placed in a home for
rodent control (Augenstein et al. 1988). Six people became ill, including a six year old female that
ingested one or more tablets and was admitted to the hospital. She was seriously ill and in profound
shock thirty-six hours after exposure. She experienced multi-system failure sixteen hours after
admission. The patient recovered and was discharged three weeks after admission.
Feldstein et al. (1991) reported on occupational exposure to phosphine among three federal
grain inspectors while inspecting wheat on a railroad train in Portland, Oregon. Respiratory
protection was not worn by the workers. After opening the seventh car, the workers noticed a very
distinct odor. Almost immediately, the workers started to develop symptoms such as facial numbness
and tingling, dizziness, nausea, and shortness of breath. In one case, a worker experienced a
headache, nausea, shortness of breath, fatigue and intermittent diaphoresis. Three weeks later, the
worker was still experiencing shortness of breath. Six weeks later, the worker no longer experienced
any symptoms. In the second case, the worker no longer experienced symptoms after four days. In
the third case, three months after the exposure, the worker complained of episodes of disorientation
and daily occipital headaches.
The Texas Department of Health and California EPA reported two incidents on exposure to
phosphine gas on September 18, 1993 and March 29, 1989. In one incident, four males, aged 12, 35,
39, and 52 years were found in a railroad car containing loose bulk lima beans by border patrol agents
four hundred fifty miles east of El Paso, Texas. After inhalation exposure from the gas, the three men
had symptoms of nausea, vomiting, headache, and abdominal discomfort. The fourth male was
twelve years old and had died from asphyxiation. In the second incident, a twenty-three year old man
was found dead in a rice-filled rail car in Maxwell, California after having entered the sealed car after
fumigation. Earlier, aluminum phosphide pellets had been loaded onto the railroad car with warning
signs posted on the car. In the editorial note by the Centers for Disease Control and Prevention, it
was noted that both EPA and the Department of Transportation have guidelines which require
warning signs on transport vehicles or freight containers that have been fumigated. Reexamination
of these guidelines are recommended to assure that appropriately placed, highly visible warning signs
printed in English and other languages that incorporate warning symbols are required.
On July 7, 1991, EPA headquarters was notified by Region 8, Denver, Colorado, of a
potential grain fumigant use problem in North Dakota. In August, 1989, a woman died that lived in
close proximity to a grain fumigation operation. Her husband was treated at a medical facility in
October, 1989 for possible organophosphate poisoning. The couple had complained about the
fumigation operation since December, 1985. The two cases were based on: (1) a review of
epidemiology, environmental, and health case material referred to headquarters from the Denver
Regional Toxicologist; and (2) supplemental case files provided by State of North Dakota personnel.
Both of these cases were considered possible pesticide poisoning incidents, based on information
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presented in the files, and using standard rankings terminology for human poisoning incidents. In the
first case, Mrs. O'Brien's death, the role of heat and chronic grain dust exposure are unclear and her
death could have resulted from other factors. In the second case, possible poisoning, Mr. O'Brien
reported symptoms of loss of peripheral motor control (uncontrollable shakiness of the hands and
feet), diarrhea, headache, burning gums, lips and teeth, skin irritation, dry mouth and throat, and
watering eyes during his hospitalization on October 7, 1989. These reported symptoms were worse
when the aerator of the fumigation facility were operating about three hundred fifty feet from their
home. October, 1989, had the highest monthly use of aluminum phosphide. Based on the available
evidence OREB concludes that both of these incidents were possibly related to aluminum phosphide.
The evidence does not support a finding of a probable or definite relationship between the exposure
and the effects.
In the late 1950s 2 adults and a child died while living in a dwelling with a party wall to a
granary being fumigated (World Health Organization 1988). It was estimated that phosphine levels
in the bedroom reached 1.2 mg/m3.
Hayes and Vaughn (1977) reported two deaths in 1973 and 1974 out of a total of 113
accidental pesticide deaths in those two years. In one case a father placed pellets behind a stove
indoors and in the other, a 17 year old climbed into a fumigated boxcar and went to sleep on the
grain.
Garry et al. (1993) reported the suspicious death of a pregnant rural woman who lived 30
yards from a large bunker-type grain storage facility. Reportedly, the facility was not tightly sealed
in contrast to standard practice.
The American Association of Poison Control Centers reported one death in 1994 when a 4
year old girl could not be aroused in the morning (Litovitz et al. 1995). Other family members were
symptomatic for headaches, nausea, and vomiting. Aluminum phosphide tablets were found in the
crawl space under the home. Other details about this case are not available.
SUMMARY/CONCLUSIONS
From the review of the California data, it appears that a majority of cases involved illnesses
to workers that entered a previously aluminum phosphide fumigated facility including buildings, fields,
tarps and chambers. Aluminum phosphide is capable of causing illness after fumigation. A large
proportion of cases have occurred when people have returned to fumigated structures to reopen and
ventilate. Often exposure results from lack of proper protective equipment and inadequate ventilation
before persons are allowed in or near the treated area. Instructions on proper disposal and storage
of this product are critical to prevent explosions and fires that result in damage to health and property.
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RECOMMENDATIONS
Aluminum phosphide is a highly toxic fumigant with the potential to cause serious poisoning
and death if mishandled. Only certified and trained personal should be allowed to handle such a
product. Currently all uses of aluminum phosphide are restricted. Consideration should be given to
making this restriction, so that only certified individuals can handle this product. Then, individuals
under the supervision of a certified applicator would not be permitted to use this product. Proper
posting of fumigated sites may need to be reexamined to assure that warning are appropriately placed,
highly visible, with symbols and language that will prevent exposures to bystanders.
Monitoring near treated sites should be considered for areas where residential dwellings are
close by. This monitoring should be conducted independently, perhaps by ORD or NIOSH, under
"real world" circumstances to determine potential risks. For workers who do reenter proper
respiratory protection and protective eyewear should be mandatory. EPA's enforcement office should
continue to make aluminum phosphide a high priority for routine inspections of misuse. Special
review is not recommended for this pesticide, but it should be given high priority for reregi strati on
so that these recommendations can be implemented soon.
References
Allen RH. Memorandum to Ruth Douglas, Product Manager 32: Aluminum phosphide 6(a)(2)
adverse effects data from Region 8 on a possible death from use of the product in grain fumigation
in North Dakota, DP Barcode D176647, August 8, 1993.
Augenstein WL, Sokol R, Kulig K, Rumack BH. Phosphine poisoning: a report of six cases
(abstract). Veterinary and Human Toxicology 30:344, 1988.
Feldstein A, Heumann M, Barnett M. Fumigant intoxication during transport of grain by railroad.
Journal of Occupational Medicine 33:64-65, 1991.
Garry VF, Good PF, Manivel JC, Perl DP. Investigation of a fatality from nonoccupational aluminum
phosphide exposure: Measurements of aluminum in tissue and body fluids as a marker of exposure.
Journal of Laboratory and Clinical Medicine 122:739-747, 1993.
Hayes WJ, Vaughn WK. Mortality from pesticides in the United States in 1973 and 1974.
Toxicology and Applied Pharmacology 42:235-252, 1977.
Litovitz TL, Felberg L, Soloway RA, Ford M, Geller R. 1994 Annual report of the American
Association of Poison Control Centers Toxic Exposure Surveillance System. American Journal of
Emergency Medicine 13:551-597, 1995.
Perrotta D, Willis T, Salzman D, Borders J, Mehler L. Deaths associated with exposure to fumigants
in railroad cars - United States. Morbidity and Mortality Weekly Report 43:489-491, 1994.
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World Health Organization. Phosphine and selected Metal Phosphides. Environmental Health
Criteria 73:1-100, 1988.
cc: Correspondence file
Aluminum phosphide file no. 066501
Bill Hazel (7509C)
RDI: ActSecHd:FDGriffith: 11/10/96: ActBrSrSci:SHummel: 12/12/96
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