[Federal Register Volume 62, Number 34 (Thursday, February 20, 1997)]
[Rules and Regulations]
[Pages 7679-7684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3931]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300453; FRL-5588-1]
RIN 2070-AB78


Zinc Phosphide; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of phosphine resulting from the use of the rodenticide zinc 
phosphide in or on the raw agricultural commodities timothy (seed, 
forage, hay), alfalfa (forage, hay), and clover (forage, hay) in 
connection with EPA's granting of an emergency exemption to the state 
of Washington under section 18 of the Federal Insecticide, Fungicide, 
and Rodenticide Act authorizing use of zinc phosphide on timothy or 
timothy-alfalfa, clover stands. This regulation establishes maximum 
permissible levels for residues of phosphine in these foods pursuant to 
section 408(l)(6) of the Federal Food, Drug and Cosmetic Act, as 
amended by the Food Quality Protection Act of 1996. The tolerances will 
expire on April 15, 1998.

DATES: This regulation is effective February 20, 1997. The entries in 
the table expire on April 15, 1998. Objections and requests for 
hearings must be received by EPA on or before April 21, 1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300453], must be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Room M3708, 401 M St., 
SW., Washington, DC 20460. Fees accompanying objections and hearing 
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: 
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and 
hearing requests filed with the Hearing Clerk identified by the docket 
control number, [OPP-300453], must also be submitted to: Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. In person, bring a copy of 
objections and hearing requests to: Crystal Mall #2, Room 1132, 1921 
Jefferson Davis Highway, Arlington, VA.

[[Page 7680]]

    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1 file 
format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket control 
number [OPP-300453]. No Confidential Business Information (CBI) should 
be submitted through e-mail. Electronic copies of objections and 
hearing requests on this rule may be filed online at many Federal 
Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration 
Division (7505W), Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: Sixth Floor, Crystal Station #1, 2800 Jefferson Davis Highway, 
Arlington, VA, 703-308-8326, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
section 408(e) and (l)(6) of the Federal Food, Drug and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for 
residues of the phosphine resulting from the use of the rodenticide 
zinc phosphide in or on timothy (seed, forage, hay), alfalfa (forage, 
hay), and clover (forage, hay) at 0.1 part per million (ppm). These 
tolerances will expire and be revoked automatically without further 
action by EPA on April 15, 1998.

I. Background and Statutory Authority

    The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) 
was signed into law August 3, 1996. FQPA amends both the 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. Among other things, FQPA amends FFDCA to bring 
all EPA pesticide tolerance-setting activities under a new section 408 
with a new safety standard and new procedures. These activities are 
described below and discussed in greater detail in the final rule 
establishing the time-limited tolerance associated with the emergency 
exemption for use of propiconazole on sorghum (61 FR 58135, November 
13, 1996, FRL-5572-9).
    New FFDCA section 408(b)(2)(A)(i) 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.'' FFCDA 
section 408(b)(2)(A)(ii) 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, but does 
not include occupational exposure. FFDCA section 408(b)(2)(C) 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....''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by FQPA. EPA has established regulations governing such 
emergency exemptions in 40 CFR part 166.
    FFDCA section 408(l)(6) requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. FFDCA section 408(l)(6) also requires EPA to promulgate 
regulations by August 3, 1997, governing the establishment of 
tolerances and exemptions under FFDCA section 408(l)(6) and requires 
that the regulations be consistent with FFDCA section 408(b)(2) and 
(c)(2) and FIFRA section 18.
    FFDCA section 408(l)(6) allows EPA to establish tolerances or 
exemptions from the requirement for a tolerance, in connection with 
EPA's granting of FIFRA section 18 emergency exemptions, without 
providing notice or a period for public comment. Thus, consistent with 
the need to act expeditiously on requests for emergency exemptions 
under FIFRA, EPA can establish such tolerances or exemptions under the 
authority of FFDCA section 408(e) and (l)(6) without notice and comment 
rulemaking.
    In establishing section 18-related tolerances and exemptions during 
this interim period before EPA issues the FFDCA section 408(l)(6) 
procedural regulation and before EPA makes its broad policy decisions 
concerning the interpretation and implementation of the new FFDCA 
section 408, EPA does not intend to set precedents for the application 
of FFDCA section 408 and the new safety standard to other tolerances 
and exemptions. Rather, these early section 18 tolerance and exemption 
decisions will be made on a case-by-case basis and will not bind EPA as 
it proceeds with further rulemaking and policy development. EPA intends 
to act on section 18-related tolerances and exemptions that clearly 
qualify under the new law.

II. Emergency Exemptions for Zinc Phosphide on Timothy and Timothy-
alfalfa/clover and FFDCA Tolerances

    EPA has authorized use under FIFRA section 18 of zinc phosphide on 
timothy and timothy-alfalfa/clover for control of the vole complex. A 
potential population of 500 voles per acre would mean significant 
economic loss during 1997. The currently available methods of control, 
including the use of zinc phosphide bait boxes and flood irrigation, 
are inadequate and impractical.
    As part of its assessment of this specific exemption, EPA assessed 
the potential risks presented by residues of phosphine on timothy 
(seed, forage, hay), alfalfa (forage, hay), and clover (forage, hay). 
In doing so, EPA considered the new safety standard in FFDCA section 
408(b)(2), and EPA decided that the necessary tolerances under FFDCA 
section 408(l)(6) would clearly be consistent with the new safety 
standard and with FIFRA section 18. These tolerances for residues of 
phosphine will permit the marketing of timothy and timothy-alfalfa/
clover treated in accordance with the provisions of the FIFRA section 
18-emergency exemptions. Consistent with the need to move quickly on 
this emergency exemption and in order to address an urgent non-routine 
situation and to ensure that the resulting food is safe and lawful, EPA 
is issuing these tolerances without notice and opportunity for public 
comment under FFDCA section 408(e) as provided in FFDCA section 
408(l)(6). Although these tolerances will expire and be revoked 
automatically without further action by EPA on April 15, 1998, under 
FFDCA section 408(l)(5), residues of phosphine not in excess of the 
amount specified in these tolerances remaining in or on timothy (seed, 
forage, hay), alfalfa (forage, hay), and clover (forage, hay) after 
that date will not be unlawful, provided the pesticide is applied 
during the term of, and in accordance with all the conditions of, the 
emergency exemptions. EPA will take action to revoke these tolerances 
earlier if any experience with, scientific data on, or

[[Page 7681]]

other relevant information on this pesticide indicate that the residues 
are not safe.
    EPA has not made any decisions about whether zinc phosphide meets 
the requirements for registration under FIFRA section 3 for use on 
timothy and timothy-alfalfa/clover or whether permanent tolerances for 
zinc phosphide for timothy (seed, forage, hay), alfalfa (forage, hay), 
and clover (forage, hay) would be appropriate. This action by EPA does 
not serve as a basis for registration of zinc phosphide by a State for 
special local needs under FIFRA section 24(c). Nor does this action 
serve as the basis for any States other than Washington to use this 
product on these crops under FIFRA section 18 without following all 
provisions of FIFRA section 18 as identified in 40 CFR part 166. For 
additional information regarding the emergency exemption for zinc 
phosphide, contact the Agency's Registration Division at the address in 
``ADDRESSES'' at the beginning of this document.

III. Risk Assessment and Statutory Findings

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides based primarily on toxicological studies using 
laboratory animals. These studies address many adverse health effects, 
including (but not limited to) reproductive effects, developmental 
toxicity, toxicity to the nervous system, and carcinogenicity. For many 
of these studies, a dose response relationship can be determined, by 
using a dose that causes adverse effects (threshold effects) and a dose 
that causes no observed effect levels (NOELs).
    Once a study has been evaluated and the observed effects have been 
determined to be threshold effects, EPA generally divides the NOEL from 
the study with the lowest NOEL by an uncertainty factor (usually 100 or 
more) to determine the reference dose (RfD). The RfD is a level at or 
below which daily aggregate exposure over a lifetime will not pose 
appreciable risks to human health. An uncertainty factor (sometimes 
called a ``safety factor'') of 100 is commonly used since it is assumed 
that people may be up to 10 times more sensitive to pesticides than the 
test animals and that one person or subgroup of the population (such as 
infants and children) could be up to 10 times more sensitive to a 
pesticide than another. In addition, EPA assesses the potential risks 
to infants and children based on the weight of the evidence of the 
toxicology studies and determines whether an additional uncertainty 
factor is warranted. Thus, an aggregate daily exposure to a pesticide 
residue at or below the RfD (expressed as 100% or less of the RfD) is 
generally considered acceptable by EPA.
    Lifetime feeding studies in two species of laboratory animals are 
conducted to screen pesticides for cancer effects. When evidence of 
increased cancer is noted in these studies, the Agency conducts a 
weight of the evidence review of all relevant toxicological data 
including short-term and mutagenicity studies and structure activity 
relationship. Once a pesticide has been classified as a potential human 
carcinogen, different types of risk assessments (e.g., linear low-dose 
extrapolations or margin of exposure (MOE) calculation based on the 
appropriate NOEL) will be carried out based on the nature of the 
carcinogenic response and the Agency's knowledge of its mode of action.
    In examining aggregate exposure, FFDCA section 408 requires that 
EPA take into account available and reliable information concerning 
exposure from the pesticide residue in the food in question, residues 
in other foods for which there are tolerances, and other non-
occupational exposures, such as where residues leach into groundwater 
or surface water that is consumed as drinking water. Dietary exposure 
to residues of a pesticide in a food commodity are estimated by 
multiplying the average daily consumption of the food forms of that 
commodity by the tolerance level or the anticipated pesticide residue 
level. The theoretical maximum residue contribution (TMRC) is an 
estimate of the level of residues consumed daily if each food item 
contained pesticide residues equal to the tolerance. The TMRC is a 
``worst case'' estimate since it is based on the assumptions that food 
contains pesticide residues at the tolerance level and that 100% of the 
crop is treated by pesticides that have established tolerances. If the 
TMRC exceeds the RfD or poses a lifetime cancer risk that is greater 
than approximately one in a million, EPA attempts to derive a more 
accurate exposure estimate for the pesticide by evaluating additional 
types of information (anticipated residue data and/or percent of crop 
treated data) which show, generally, that pesticide residues in most 
foods when they are eaten are well below established tolerances.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. Zinc phosphide is already registered by EPA for outdoor 
residential lawn, nursery, right-of-way, recreational area, and other 
non-food uses, as well as several food use registrations. Phosphine is 
a highly reactive gas that reacts with raw agricultural commodities to 
form bound phosphate residues. The Agency stated in a registration 
standard for zinc phosphide (June 23, 1982) that a tolerance of 0.1 ppm 
for phosphine resulting from the use of zinc phosphide would be 
allowable for raw agricultural commodities, provided the bound 
phosphate residues can be fully characterized. At the time the 
registration standard was issued, the Agency identified 70% of the 
bound phosphate residues in treated commodities as consisting of 
oxyphosphorus acids, which are considered toxicologically insignificant 
at the levels found in treated commodities. Data have since been 
submitted which demonstrate that the remaining 30% of residues consists 
of oxidation products of phosphine (oxyphosphorus acids and/or their 
salts), which are also considered toxicologically insignificant at the 
levels found in treated commodities. EPA believes it has sufficient 
data to assess the hazards of zinc phosphide and to make a 
determination on aggregate exposure, consistent with FFDCA section 
408(b)(2), for the time-limited tolerances for residues of phosphine 
resulting from the use of zinc phosphide in or on timothy (seed, 
forage, hay), alfalfa (forage, hay), and clover (forage, hay) at 0.1 
part per million (ppm). EPA's assessment of the dietary exposures and 
risks associated with establishing these tolerances follows.

A. Toxicological Profile

    1. Chronic toxicity. Based on the available chronic toxicity data, 
EPA's Office of Pesticide Programs (OPP) has established the RfD for 
zinc phosphide at 0.0003 milligram(mg)/kilogram(kg)/day. The RfD was 
established based on an lowest effect level (LEL) of 3.48 mg/kg/day 
from an open literature 90-day rat feeding study. Effects observed at 
the LEL were decreased food consumption and body weight. An uncertainty 
factor of 10,000 was used due to data gaps and the absence of a NOEL in 
the study. The Agency has recently reviewed a 90-day gavage study in 
rats which had a NOEL

[[Page 7682]]

of 0.1 mg/kg/day and a LEL of 1.0 mg/kg/day. The LEL of 1.0 mg/kg/day 
was based on increased mortality and kidney nephrosis in male rats.
    2. Acute toxicity. No toxicology studies were identified by OPP 
which demonstrated the need for an acute dietary risk assessment.
    3. Short-term, non-dietary inhalation and dermal toxicity. Since 
10% zinc phosphide tracking powder has been classified in Toxicity 
Category IV (LC50 > 19.6 mg/liter (L)), inhalation exposure 
resulting from this FIFRA section 18 action is not considered 
toxicologically significant. For short-term and intermediate dermal MOE 
calculations, EPA's Health Effects Division (HED), OPP recommended use 
of the adjusted acute dermal LD50 NOEL of 1,000 mg/kg from the 
acute dermal toxicity study in rabbits. In the absence of other dermal 
toxicity data, the acute NOEL dose of 1,000 mg/kg was divided by a 100-
fold uncertainty factor to approximate a 3-month dermal NOEL for worker 
dermal exposure. The 3-month dermal NOEL is 10 mg/kg/day. At the LEL of 
2,000 mg/kg in the rabbit dermal LD50 study, the animals lost 
weight, but no mortalities were observed up to 5,000 mg/kg highest dose 
tested (HDT). Actual risk from dermal exposure is likely to be 
significantly less, since zinc phosphide reacts with water and stomach 
acid to produce the toxic gas phosphine from oral, but not dermal, 
exposure.
    4. Carcinogenicity. Zinc phosphide has not been reviewed for 
carcinogenicity. OPP has waived carcinogenicity data requirements for 
zinc phosphide on the basis that exposures to zinc phosphide are 
controlled to prevent exposures to humans. Applications to crop areas 
are such that the zinc phosphide will dissipate.

B. Aggregate Exposure

    1. Tolerances are already established for residues of the phosphine 
resulting from the use of zinc phosphide on several raw agricultural 
commodities (40 CFR 180.284 (a) and (b)). There is no reasonable 
expectation of secondary residues in meat, milk, poultry, or eggs (40 
CFR 180.6(a)(3)). Any residues of zinc phosphide ingested by livestock 
would be metabolized to naturally occurring phosphorous compounds. No 
human food items are derived from timothy grown for seed or mixed 
stands of timothy-alfalfa/clover produced for hay. Therefore, humans 
will receive no additional dietary exposure to phosphine as a result of 
establishment of this tolerance.
    2. For the purpose of assessing chronic dietary exposure from zinc 
phosphide, EPA assumed tolerance level residues and 100% of crop 
treated for the proposed and existing food uses of zinc phosphide. 
These conservative assumptions result in over estimation of human 
dietary exposures.
    3. Other potential sources of exposure of the general population to 
residues of pesticides are residues in drinking water and exposure from 
non-occupational sources. There is no information on zinc phosphide 
(phosphine) residues in ground water and runoff in the EPA's 
Environmental Fate and Effects Division (EFED) One-Liner Data Base. 
There is no established maximum concentration level (MCL) for residues 
of zinc phosphide (phosphine) in drinking water. No drinking water 
health advisory levels have been established for zinc phosphide 
(phosphine). There is no entry for zinc phosphide (phosphine) in the 
``Pesticides in Groundwater Database'' (EPA 734-12-92-001, September 
1992). Based on the available studies used in EPA's assessment of 
environmental risk, EPA does not anticipate exposure to residues of 
zinc phosphide (phosphine) in drinking water.
    4. There are residential uses of zinc phosphide and EPA 
acknowledges that there may be short-, intermediate-, and long-term 
non-occupational, non-dietary exposure scenarios. OPP has identified a 
toxicity endpoint for an intermediate-term residential risk assessment. 
However, no acceptable reliable dermal exposure data to assess these 
potential risks are available at this time. Given the time-limited 
nature of this request, the need to make emergency exemption decisions 
quickly, and the significant scientific uncertainty at this time about 
how to aggregate non-occupational exposure with dietary exposure, the 
Agency will make its safety determination for these tolerances based on 
those factors which it can reasonably integrate into a risk assessment.
    5. At this time, the Agency has not made a determination that zinc 
phosphide and other substances that may have a common mode of toxicity 
would have cumulative effects. Given the time-limited nature of this 
request, the need to make emergency exemption decisions quickly, and 
the significant scientific uncertainty at this time about how to define 
common mode of toxicity, the Agency will make its safety determination 
for these tolerances based on those factors which can reasonably 
integrate into a risk assessment. For purposes of these tolerances 
only, the Agency is considering only the potential risks of zinc 
phosphide in its aggregate exposure.

C. Safety Determinations For U.S. Population

    No human food items are derived from timothy grown for seed or 
mixed stands of timothy-alfalfa/clover produced for hay. Taking into 
account the completeness and reliability of the toxicity data, EPA has 
concluded that dietary exposure to zinc phosphide from published 
tolerances (including recently published time-limited tolerances for 
potatoes and sugar beets) will utilize 27.5% of the RfD for the U.S. 
population. EPA does not anticipate chronic exposure to residues of 
zinc phosphide (phosphine) in drinking water.
    D. Determination of Safety for Infants and Children
    1. There were no developmental findings in rats up to a maternally 
toxic dose of 4.0 mg/kg/day zinc phosphide nor in mice at 4.0 mg/kg/day 
HDT. A comparison of the NOEL of 0.1 mg/kg/day in the recent 90-day rat 
gavage study and the NOELs for developmental toxicity in rats and mice 
(4.0 mg/kg/day) provides a 40-fold difference, which demonstrates that 
there are no special prenatal sensitivities for infants and children. 
OPP has waived teratogenicity in the rabbit and the two-generation 
reproduction study in the rat data requirements for zinc phosphide on 
the basis that exposures to zinc phosphide are controlled to prevent 
exposures to humans. Applications to crop areas are such that the zinc 
phosphide will dissipate. Since there are no reproduction studies with 
zinc phosphide, the post-natal potential for effects from zinc 
phosphide in infants and children cannot be fully evaluated. However, 
the above information, together with the uncertainty factor of 10,000 
utilized to calculate the RfD for zinc phosphide, is considered 
adequate protection for infants and children with respect to prenatal 
and postnatal development against dietary exposure to zinc phosphide 
residues, and therefore, EPA has determined that an additional 10-fold 
safety factor is not appropriate.
    2. EPA has concluded that the percent of the RfD that will be 
utilized by chronic dietary exposure to residues of zinc phosphide 
ranges from 6.8% for nursing infants (<1 year old) up to 59.9% for 
children 1 to 6 years old. However, this calculation assumes tolerance 
level residues for all commodities and is therefore an over estimate of 
dietary risk. Refinement of the dietary risk assessment by using 
anticipated residue data would reduce dietary exposure. As mentioned 
before,

[[Page 7683]]

EPA does not expect chronic exposure from drinking water.

V. Other Considerations

    The metabolism of zinc phosphide in plants and animals is 
adequately understood for the purposes of these tolerances. The residue 
of concern is unreacted zinc phosphide, measured as phosphine, that may 
be present. Adequate methods for purposes of data collection and 
enforcement of tolerances for zinc phosphide residues as phosphine gas 
are available. Methods for determining zinc phosphide residues of 
phosphine gas are described in PAM, Vol. II, as Method A. There are no 
Codex tolerances for timothy (seed, forage, hay), alfalfa (forage, 
hay), and clover (forage, hay).

VI. Conclusion

    EPA concludes that there is a reasonable certainty of no harm to 
consumers, including infants and children, from aggregate exposure to 
zinc phosphide based on the following considerations. First, approval 
of these tolerances results in no additional exposure to consumers. 
Second, EPA has used a 10,000-fold safety factor in assessing the risk 
estimate posed by zinc phosphide. Third, this pesticide is being used 
to address an emergency situation and EPA, therefore, must make a quick 
decision. Fourth, because these tolerances are for an emergency 
situation, extended use under these tolerances are not authorized. 
Therefore, tolerances in connection with the FIFRA section 18 emergency 
exemptions are established for residues of phosphine resulting from the 
use of zinc phosphide in timothy (seed, forage, hay), alfalfa (forage, 
hay), and clover (forage, hay) at 0.1 part per million (ppm). These 
tolerances will expire and be automatically revoked without further 
action by EPA on April 15, 1998.

VII. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new FFDCA section 408(e) and (l)(6) as was provided in the old FFDCA 
section 408 and section 409. However, the period for filing objections 
is 60 days, rather than 30 days. EPA currently has procedural 
regulations which govern the submission of objections and hearing 
requests. These regulations will require some modification to reflect 
the new law. However, until those modifications can be made, EPA will 
continue to use those procedural regulations with appropriate 
adjustments to reflect the new law.
    Any person may, by April 21, 1997, file written objections to any 
aspect of this regulation (including the automatic revocation 
provision) and may also request a hearing on those objections. 
Objections and hearing requests must be filed with the Hearing Clerk, 
at the address given in ``ADDRESSES'' at the beginning of this document 
(40 CFR 178.20). A copy of the objections and/or hearing requests filed 
with the Hearing Clerk should be submitted to the OPP docket for this 
rulemaking. The objections submitted must specify the provisions of the 
regulation deemed objectionable and the grounds for the objections (40 
CFR 178.25). Each objection must be accompanied by the fee prescribed 
by 40 CFR 180.33(i). If a hearing is requested, the objections must 
include a statement of the factual issues on which a hearing is 
requested, the requestor's contentions on such issues, and a summary of 
any evidence relied upon by the requestor (40 CFR 178.27). A request 
for a hearing will be granted if the Administrator determines that the 
material submitted shows the following: There is genuine and 
substantial issue of fact; there is a reasonable possibility that 
available evidence identified by the requestor would, if established, 
resolve one or more of such issues in favor of the requestor, taking 
into account uncontested claims or facts to the contrary; and 
resolution of the factual issues in the manner sought by the requestor 
would be adequate to justify the action requested (40 CFR 178.32). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as Confidential Business Information (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.

VIII. Public Record

    A record has been established for this rulemaking under docket 
control number [OPP-300453]. A public version of this record, which 
does not include any information claimed as CBI, is available for 
inspection from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 
legal holidays. The public record is located in Room 1132 of the Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    The official record for this rulemaking, as well as the public 
version, as described above, is kept in paper form. Accordingly, in the 
event there are objections and hearing requests, EPA will transfer any 
copies of objections and hearing requests received electronically into 
printed, paper form as they are received and will place the paper 
copies in the official rulemaking record.
    The official rulemaking record is the paper record maintained at 
the address in ``ADDRESSES'' at the beginning of this rule.

IX. Regulatory Assessment Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is not a ``significant regulatory action'' and, since this 
action does not impose any information collection requirements as 
defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is 
not subject to review by the Office of Management and Budget. In 
addition, this action does not impose any enforceable duty or contain 
any unfunded mandate as described in the Unfunded Mandates Reform Act 
of 1995 (Pub. L. 104-4), or require prior consultation with State 
officials as specified by Executive Order 12875 (58 FR 58093, October 
28, 1993), or special considerations as required by Executive Order 
12898 (59 FR 7629, February 16, 1994).
    Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act 
(APA) as amended by the Small Business Regulatory Enforcement Fairness 
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted 
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 General Accounting Office prior to publication of the 
rule in today's Federal Register. This rule is not a ``major rule'' 
asdefined by 5 U.S.C. 804(2) of the APA as amended.

List of Subjects in 40 CFR Part 180

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

    Dated: February 6, 1997.

Peter Caulkins,

Acting Director, Office of Pesticide Programs.

[[Page 7684]]

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:
    Authority: 21 U.S.C. 346a and 371.


    2. In Sec. 180.284, paragraph (c) is amended by revising the 
introductory text and adding in alphabetical order new entries to the 
table to read as follows:


Sec. 180.284   Zinc phosphide, tolerances for residues.

                *    *    *    *   *
    (c) Time-limited tolerances are established for residues of 
phosphine resulting from the use of the rodenticide zinc phosphide in 
connection with use of the pesticide under FIFRA section 18 emergency 
exemptions granted by EPA. The tolerances are specified in the 
following table. The tolerances expire on the date specified in the 
table.

                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    Revocation Date 
------------------------------------------------------------------------
Alfalfa (forage)................          0.1           April 15, 1998  
Alfalfa (hay)...................          0.1           April 15, 1998  
Clover (forage).................          0.1           April 15, 1998  
Clover (hay)....................          0.1           April 15, 1998  
              *        *        *        *        *                     
Timothy (forage)................          0.1           April 15, 1998  
Timothy (hay)...................          0.1           April 15, 1998  
Timothy (seed)..................          0.1           April 15, 1998  
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[FR Doc. 97-3931 Filed 2-19-97; 8:45 am]
BILLING CODE 6560-50-F