[Federal Register Volume 68, Number 189 (Tuesday, September 30, 2003)]
[Rules and Regulations]
[Pages 56189-56195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24844]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2003-0319; FRL-7329-9]


Zinc Phosphide; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
phosphine resulting from the use of the rodenticide zinc phosphide in 
or on alfalfa, forage; alfalfa hay; barley, grain; barley, hay; barley, 
straw; bean, dry, seed; beet, sugar, roots; beet, sugar, tops; potato; 
timothy, forage; timothy, hay; wheat, forage; wheat, grain; wheat, hay; 
and wheat, straw. The Interregional Research Project Number 4 (IR-4) 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), as amended by the Food Quality Protection Act of 1996 
(FQPA).

DATES: This regulation is effective September 30, 2003. Objections and 
requests for hearings, identified by docket ID number OPP-2003-0319, 
must be received on or before December 1, 2003.

ADDRESSES: Written objections and hearing requests may be submitted 
electronically, by mail, or through hand delivery/courier. Follow the 
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW.,Washington, DC 20460-0001; telephone 
number: (703) 305-7610; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The North American Industrial Classification System (NAICS) codes have 
been provided to assist you and others in determining whether this 
action might apply to certain entities. Potentially affected entities 
may include, but are not limited to:
    [sbull] Crop production (NAICS code 111)
    [sbull] Animal production (NAICS code 112)
    [sbull] Food manufacturing (NAICS code 311)
    [sbull] Pesticide manufacturing (NAICS code 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. If you have any questions regarding the applicability of this 
action to a particular entity, consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this 
action under docket identification (ID) number OPP-2003-0319. The 
official public docket consists of the documents specifically 
referenced in this action, any public comments received, and other 
information related to this action. Although a part of the official 
docket, the public docket does not include Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute. The official public docket is the collection of materials 
that is available for public viewing at the Public Information and 
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The docket telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr/. A frequently updated 
electronic version of 40 CFR part 180 is available at http: //
www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180--00.html/, a 
beta site currently under development. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gov/opptsfrs/home/guidelin.htm/.
    An electronic version of the public docket is available through 
EPA's electronic public docket and comment system, EPA Dockets. You may 
use EPA Dockets at http://www.epa.gov/edocket/

[[Page 56190]]

 to submit or view public comments, access the index listing of the 
contents of the official public docket, and to access those documents 
in the public docket that are available electronically. Although not 
all docket materials may be available electronically, you may still 
access any of the publicly available docket materials through the 
docket facility identified in Unit I.B.1. Once in the system, select 
``search,'' then key in the appropriate docket ID number.

II. Background and Statutory Findings

    In the Federal Register of July 9, 2003 (68 FR 40939) (FRL-7314-1), 
EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, 
as amended by FQPA (Public Law 104-170), announcing the filing of 
pesticide petitions (PP 2E6419, PP 1E6306, PP 1E6270, PP 1E6337, PP 
9E5082, PP 0E6199, and PP 1E6292) by IR-4, 681 U. S. Highway 1 
South, North Brunswick, NJ 08902-3390. That notice included a summary 
of the petitions prepared by the registrant, HACO, Inc., P.O. Box 7190, 
Madison, WI 53707. The Agency received a number of comments on the 
notice of filing published on July 9, 2003 (68 FR 40939). All comments 
were in favor of establishing the food tolerances proposed in the 
notice.
    The petitions requested that 40 CFR 180.284 be amended by 
establishing tolerances for residues of phosphine resulting from the 
use of the rodenticide zinc phosphide, in or on alfalfa, forage and 
alfalfa, hay at 0.1 parts per million (ppm); barley, grain and barley, 
hay at 0.05 ppm, and barley, straw at 0.2 ppm; bean, dry at 0.05 ppm; 
beet, sugar, roots at 0.05 ppm and beet, sugar, tops at 0.2 ppm; potato 
at 0.05 ppm; timothy, forage and timothy, hay at 0.05 ppm; and wheat, 
grain, wheat, hay, and wheat, straw at 0.05 ppm.
    EPA is also deleting several established tolerances in Sec.  
180.284(b) that are no longer needed, as a result of this action. The 
tolerance deletions are time-limited tolerances established under 
section 18 emergency exemptions that are superceded by the 
establishment of general tolerances for zinc phosphide under Sec.  
180.284(a).
    The following deletions to Sec.  180.284(b) are replaced in Sec.  
180.284(a):
    1. Delete the time-limited tolerances for barley, grain at 0.01 
ppm, barley, hay at 0.20 ppm, and barley straw at 0.02 ppm. Tolerances 
for barley, grain at 0.05 ppm, barley, hay at 0.2 ppm, and barley, 
straw at 0.2 ppm are established by this action under Sec.  180.284(a).
    2. Delete the time-limited tolerances for beet, sugar, roots at 
0.05 ppm and beet, sugar, tops at 0.1 ppm. Tolerances for sugar, beet, 
roots are established at 0.05 ppm and sugar, beet, tops at 0.2 ppm 
under Sec.  180.284(a).
    3. Delete the time-limited tolerance for potato at 0.05 ppm. A 
tolerance for potato is established at 0.05 ppm under Sec.  180.284(a).
    4. Delete the time-limited tolerances for timothy, forage and 
timothy, hay at 0.1 ppm. Tolerances for timothy, forage and timothy, 
hay are established at 0.5 ppm under Sec.  180.284(a).
    5. Delete the time-limited tolerances for wheat, grain, wheat, hay 
and wheat, straw at 0.01 ppm. Tolerances for wheat, grain, wheat, hay, 
wheat, straw, and wheat, forage are established at 0.05 ppm under Sec.  
180.284(a).
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see the final rule on 
Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-
5754-7).

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2) of the FFDCA, for tolerances for residues of phosphine 
resulting from the use of the rodenticide zinc phosphide on alfalfa, 
forage and alfalfa, hay at 0.2 ppm; barley, grain at 0.05; barley, hay 
at 0.2 ppm; barley, straw at 0.2 ppm; bean, dry, seed at 0.05 ppm; 
beet, sugar, roots at 0.05 ppm; beet, sugar, tops at 0.2 ppm; potato at 
0.05 ppm; timothy, forage and timothy, hay at 0.5 ppm; and wheat, 
forage, wheat, grain, wheat hay, and wheat, straw at 0.05 ppm. EPA's 
assessment of exposures and risks associated with establishing the 
tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by zinc phosphide are 
discussed in Table 1 of this unit as well as the no observed adverse 
effect level (NOAEL) and the lowest observed adverse effect level 
(LOAEL) from the toxicity studies reviewed.

                                Table 1.--Subchronic, Chronic, and Other Toxicity
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              Guideline No.                         Study Type                           Results
----------------------------------------------------------------------------------------------------------------
870.3100                                   90-Day oral toxicity rodents  NOAEL = 0.1 milligram/kilogram/day (mg/
                                                                          kg/day)
                                                                         LOAEL = 1.0 mg/kg/day based on
                                                                          increased mortality and kidney
                                                                          hydronephrosis in male rats
----------------------------------------------------------------------------------------------------------------
870.3150                                   90-Day oral toxicity in       Waived
                                            nonrodents
----------------------------------------------------------------------------------------------------------------
870.3200                                   21/28-Day dermal toxicity     Waived
----------------------------------------------------------------------------------------------------------------

[[Page 56191]]

 
870.3700                                   Prenatal developmental in     Maternal NOAEL = 2.0 mg/kg/day
                                            rodents                      Maternal LOAEL = 4.0 mg/kg/day based on
                                                                          mortality
                                                                         Developmental NOAEL = >4.0 mg/kg/day
                                                                         Developmental LOAEL = not established
----------------------------------------------------------------------------------------------------------------
870.370                                    Prenatal developmental in     Waived
                                            nonrodents
----------------------------------------------------------------------------------------------------------------
870.3800                                   Reproduction and fertility    Waived
                                            effects
----------------------------------------------------------------------------------------------------------------
870.4100                                   Chronic toxicity rodents      Waived
----------------------------------------------------------------------------------------------------------------
870.4100                                   Chronic toxicity dogs         Waived
----------------------------------------------------------------------------------------------------------------
870.4200                                   Carcinogenicity rats          Waived
----------------------------------------------------------------------------------------------------------------
870.4300                                   Carcinogenicity mice          Waived
----------------------------------------------------------------------------------------------------------------
870.5375                                   Mutagenicity-mouse lymphoma   Positive for gene mutation, with and
                                                                          without S9 mammalian metabolic
                                                                          mutation
----------------------------------------------------------------------------------------------------------------
870.5385                                   Chromosomal aberration        Negative for gene mutation
----------------------------------------------------------------------------------------------------------------
870.5500                                   Mutagenicity-Ames             Negative for gene mutation, with and
                                                                          without S9 mammalian metabolic
                                                                          mutation
----------------------------------------------------------------------------------------------------------------
870.620                                    Acute neurotoxicity           NOAEL = >10 mg/kg/day
                                            screening battery            LOAEL = not established
----------------------------------------------------------------------------------------------------------------
870.6200                                   Subchronic neurotoxicity      NOAEL = 0.1 mg/kg/day
                                            screening battery            LOAEL = 2.0 mg/kg/day based on clinical
                                                                          toxicity (not neurotoxicity)
----------------------------------------------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological level of concern 
(LOC). However, the lowest dose at which adverse effects of concern are 
identified (the LOAEL) is sometimes used for risk assessment if no 
NOAEL was achieved in the toxicology study selected. An uncertainty 
factor (UF) is applied to reflect uncertainties inherent in the 
extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns. An UF of 100 is routinely used, 10X to account for 
interspecies differences and 10X for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factors 
(SF) is retained due to concerns unique to the FQPA, this additional 
factor is applied to the RfD by dividing the RfD by such additional 
factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is 
a modification of the RfD to accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10-\6\ or one in a million). 
Under certain specific circumstances, MOE calculations will be used for 
the carcinogenic risk assessment. In this non-linear approach, a 
``point of departure'' is identified below which carcinogenic effects 
are not expected. The point of departure is typically a NOAEL based on 
an endpoint related to cancer effects though it may be a different 
value derived from the dose response curve. To estimate risk, a ratio 
of the point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints for zinc phosphide used for human risk assessment is shown in 
Table 2 of this unit:

[[Page 56192]]



     Table 2.-- Summary of Toxicological Dose and Endpoints for Zinc
               Phosphide for Use in Human Risk Assessment
------------------------------------------------------------------------
                                                           Study and
        Exposure Scenario          Dose Used in Risk     Toxicological
                                    Assessment, UF          Effects
------------------------------------------------------------------------
Acute dietary (general            NOAEL = 2.0 mg/kg/  Developmental
 population including infants      day                 Toxicity Study-
 and children)                    UF = 100..........   Rat
                                  Acute RfD = 0.02    LOAEL = 4.0 mg/kg/
                                   mg/kg/day.          day based on
                                                       maternal deaths
                                                       on gestation day
                                                       10 (i.e., after 4
                                                       doses) though day
                                                       16
------------------------------------------------------------------------
Chronic dietary (all              NOAEL= 0.1 g/kg/    90-Day Oral
 populations)                      day                 Toxicity Study-
                                  UF = 1,000........   Rats
                                  Chronic RfD =       LOAEL = 1.0 mg/kg/
                                   0.0001 mg/kg/day.   day based on
                                                       increased
                                                       mortality,
                                                       increased
                                                       absolute and
                                                       relative liver
                                                       weight, and
                                                       hematological
                                                       alterations
------------------------------------------------------------------------
Short-term dermal (1 to 7 days)   Not applicable      Dermal exposure is
Intermediate-term (1 week to                           not expected
 several months).                                      since baits are
Long-term dermal (several months                       not absorbable
 to lifetime).                                         and Zn phosphide
(Residential)...................                       powder is too
                                                       polar to be
                                                       absorbed through
                                                       the skin
------------------------------------------------------------------------
Short-term inhalation (1 to 7     Not applicable      Inhalation
 days)                                                 exposure is not
Intermediate-term inhalation (1                        expected. End-use
 week to several months).                              baits are not
Long-term inhalation (several                          powdery or
 months to lifetime).                                  respirable
(Residential)...................
------------------------------------------------------------------------
Cancer (oral, dermal,             Not applicable      Not applicable
 inhalation)
------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.284(a)) for residues of phosphine resulting 
from the use of zinc phosphide, in or on a variety of raw agricultural 
commodities including: Grape (0.01 ppm), grass (rangeland) (0.1 ppm), 
and sugarcane (0.01 ppm). Tolerances with regional registration are 
established 40 CFR 180.284(c) for zinc phosphide residues in or on 
globe artichokes (0.01 ppm), sugar beet (roots) (0.04 ppm), and sugar 
beet tops (0.02 ppm). Section 18 tolerances at 40 CFR 180.284(b) 
currently exist for zinc phosphide residues in or on: Alfalfa forage, 
alfalfa hay, barley grain, barley hay, barley straw, sugar beets 
(tops), sugar beet roots, timothy, hay, timothy, forage, potato, wheat 
grain, wheat hay, and wheat straw.
    Based on residue data from field trials conducted in support of the 
subject tolerances, EPA concludes that acute and chronic dietary 
exposure associated with the proposed uses of zinc phoshide is 
unlikely. Residues were below the Level of Quantitation (LOQ) (<0.05 or 
<0.1 ppm) in crops, except for the livestock feed items alfalfa forage, 
sugar beet tops, and timothy forage. Alfalfa forage, sugar beet tops, 
and timothy hay are not direct human food items; rather, they are used 
as animal feeds. Because residues of zinc phosphide ingested by 
livestock would be immediately converted to phosphine and metabolized 
to naturally occurring phosphorus compounds, residues of zinc phosphide 
in livestock feeds are not expected to result in residues of zinc 
phosphide in livestock commodities. Also, the act of processing and 
washing will not allow for unreacted zinc phosphide to remain in or on 
food items. In addition, residues are not expected in wheat and barley 
grain since zinc phosphide will be applied to barley and wheat prior to 
the formation of seed heads.
    2. Dietary exposure from drinking water. No drinking water risk 
assessment was performed for zinc phosphide because no residues are 
expected in either ground water or surface water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Zinc phosphide is currently registered in pellet and bait form for 
use on residential non-food sites to control mammals (primarily 
rodents) in areas such as commercial establishments, public areas 
(parks), dumps, and homes. A detailed residential exposure assessment 
is contained in the Reregistration Eligibility Decision (RED) Document, 
EPA 738-R-98-006, July 1998, for zinc phosphide.
    There were no endpoints identified for zinc phosphide use in a 
residential assessment except for accidental ingestion. The residential 
exposure assessment evaluated exposure from accidental ingestion of 
zinc phosphide. No other residential exposure assessment was either 
expected or, if expected, found to have any hazard potential.
    Although having considered that accidental ingestion of zinc 
phosphide baits may occur with respect to a very small number of 
children, EPA has concluded that this potential exposure is not 
appropriate for inclusion in evaluating the safety of aggregate 
exposure of consumers and major identifiable subgroups of consumers to 
zinc phosphide. Unlike other residential uses (such as a turf use) that 
potentially may result in exposures to significant groups of children, 
the subgroup of children that may consume baits in childproof bait 
stations is very tiny. This small subgroup of children would not 
qualify as a major identifiable subgroup of consumers.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular

[[Page 56193]]

pesticide's residues and ``other substances that have a common 
mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether zinc phosphide has a common mechanism of toxicity with other 
substances. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, EPA 
has not made a common mechanism of toxicity finding as to zinc 
phosphide and any other substances, and zinc phosphide does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has not assumed that 
zinc phosphide has a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see the policy statements 
released by EPA's Office of Pesticide Programs concerning common 
mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional tenfold margin of safety for infants and children 
in the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    3. Conclusion. EPA has waived a significant portion of the data 
normally required in establishing a tolerance for a pesticide chemical, 
in evaluating the petitions for zinc phosphide. This data waiver is 
based on data showing that dietary exposure is unlikely to result from 
agricultural uses of zinc phosphide. Based on these exposure data, EPA 
concludes there are reliable data supporting a conclusion that no 
additional safety factor is necessary to protect the safety of infants 
and children.

E. Aggregate Risks and Determination of Safety

    Zinc phosphide has both food and non-occupational uses; therefore, 
the considerations for aggregate exposure are those from food, drinking 
water, and residential (non-occupational) sources.
    The Agency has concluded that there will be no human dietary 
exposure from the proposed or registered uses of zinc phosphide. Thus, 
exposure to zinc phosphide from food is not a component of the acute 
and chronic aggregate exposure assessment.
    1. Acute risk. The Agency has concluded that there will be no human 
dietary exposure from the proposed or registered uses of zinc 
phosphide. Thus, exposure to zinc phosphide from food is not a 
component of the acute and chronic aggregate exposure assessment.
    2. Chronic risk. The Agency has concluded that there will be no 
human dietary exposure from the proposed or registered uses of zinc 
phosphide. Exposure to zinc phosphide from food and water is not a 
component of the acute and chronic aggregate exposure assessment.
    There are no residential uses for zinc phosphide that result in 
chronic residential exposure to zinc phosphide. Based on the use 
pattern, chronic residential exposure to residues of zinc phosphide is 
not expected. There is no potential for chronic dietary exposure to 
zinc phosphide in food and drinking water.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account chronic dietary 
food and water (considered to be a background exposure levels) plus 
indoor and outdoor residential exposure. No short-term or intermediate-
term dermal, oral or inhalation toxicological endpoints were identified 
for zinc phosphide.
    Further, no incidental oral exposure is expected given the 
conditions of use. Although potentially accidental ingestion of zinc 
phosphide bait may occur in rare instances, the subgroup of children 
that are exposed in such a manner is not a major identifiable subgroup 
of consumers.
    4. Aggregate cancer risk for U.S. population. Since chronic 
exposure and risk associated with the use of zinc phosphide is 
negligible, no risk of cancer is expected from the use of zinc 
phosphide.
    5. Determination of safety. There is no drinking water, 
residential, nor dietary component to acute and chronic aggregate 
exposure to zinc phosphide residues. Based on these exposure 
assessments, EPA concludes that there is a reasonable certainty that no 
harm will result to adults, infants and children from aggregate 
exposure to zinc phosphide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Acceptable methods are available for enforcement and data 
collection purposes for plant commodities. The Pesticide Analytical 
Manual (PAM), Vol. II lists, under aluminum phosphide, a colorimetric 
method and a gas liquid chromatography with flame photometric detection 
(GLC/FPD) method as Methods A and B, respectively. Both methods 
determine the level of phosphine liberated when zinc phosphide is 
exposed to dilute acid solutions. EPA has determined that Method A is 
acceptable for enforcement. Data submitted in support of the 
established tolerances were collected by one of these two methods. Data 
submitted in support of the proposed tolerances were collected by the 
GLC/FPD method or a similar method
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; e-mail address: 
[email protected].

B. International Residue Limits

    There are no international harmonization issues associated with 
this action since there are no Codex, Mexican or Canadian maximum 
residue levels (MRLs) or tolerances for zinc phosphide on any crop.

V. Conclusion

    Therefore, the tolerances are established for residues of phosphine 
resulting from the use of zinc phosphide in or on alfalfa, forage and 
alfalfa, hay at 0.2 ppm; barley, grain, at 0.05 ppm, barley, hay and 
barley, straw at 0.2 ppm; bean, dry, seed at 0.05 ppm; beet, sugar, 
roots at 0.05 ppm and beet, sugar, tops at 0.2 ppm; potato at 0.05 ppm; 
timothy, forage and timothy, hay at 0.5 ppm; and wheat, forage, wheat, 
grain, wheat hay, and wheat, straw at 0.05 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA, EPA will continue

[[Page 56194]]

to use those procedures, with appropriate adjustments, until the 
necessary modifications can be made. The new section 408(g) of the 
FFDCA provides essentially the same process for persons to ``object'' 
to a regulation for an exemption from the requirement of a tolerance 
issued by EPA under new section 408(d) of FFDCA, as was provided in the 
old sections 408 and 409 of the FFDCA. However, the period for filing 
objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number OPP-2003-0319 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before December 
1, 2003.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is 
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Office of the Hearing Clerk is 
(703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.1. Mail your 
copies, identified by docket ID number OPP-2003-0319, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the 
PIRIB described in Unit I.B.1. You may also send an electronic copy of 
your request via e-mail to: [email protected]. Please use an ASCII 
file format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of the FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and

[[Page 56195]]

responsibilities among the various levels of government, as specified 
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999). Executive Order 13132 requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by State and local 
officials in the development of regulatory policies that have 
federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency 
has determined that this rule does not have any ``tribal implications'' 
as described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: September 25, 2003.
Debra Edwards,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

0
2. Section 180.284 is amended by adding commodities to the table in 
paragraph (a) and removing the following entries from the table in 
paragraph (b): ``barley, grain,'' ``barley, hay,'' ``barley, straw,'' 
``beet, sugar, roots,'' ``beet, sugar, tops,'' ``potato,'' ``timothy, 
forage,'' ``timothy, hay,'' ``wheat, grain,'' ``wheat, hay,'' and 
``wheat, straw'' to read as follows:


Sec.  180.284   Zinc phosphide; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
Alfalfa, forage                                                      0.2
Alfalfa, hay                                                         0.2
Barley, grain                                                       0.05
Barley, hay                                                          0.2
Barley, straw                                                        0.2
Bean, dry, seed                                                     0.05
Beet, sugar, roots                                                  0.05
Beet, sugar, tops                                                    0.2
                                * * * * *
Potato                                                              0.05
                                * * * * *
Timothy, hay                                                         0.5
Timothy, forage                                                      0.5
Wheat, forage                                                       0.05
Wheat, grain                                                        0.05
Wheat, hay                                                          0.05
Wheat, straw                                                        0.05
------------------------------------------------------------------------

* * * * *

[FR Doc. 03-24844 Filed 9-26-03; 11:11 am]
BILLING CODE 6560-50-S