[Federal Register Volume 62, Number 6 (Thursday, January 9, 1997)]
[Rules and Regulations]
[Pages 1288-1293]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-512]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[OPP-300448; FRL-5581-9]
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

[[Page 1289]]

raw agricultural commodities sugarbeets and potatoes in connection with 
crisis exemptions declared by the state of Idaho under section 18 of 
the Federal Insecticide, Fungicide, and Rodenticide Act authorizing use 
of zinc phosphide on sugarbeets and potatoes. 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 and be revoked automatically without 
further action by EPA on October 15, 1997.
DATES: This regulation becomes effective January 9, 1997. This 
regulation expires and is revoked automatically without further action 
by EPA on October 15, 1997. Objections and requests for hearings must 
be received by EPA on or before March 10, 1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket number, [OPP-300448], must be submitted to: Hearing Clerk 
(1900), Environmental Protection Agency, Rm. 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 document 
control number, [OPP-300448], 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 Rm. 1132, CM #2, 1921 Jefferson 
Davis Hwy., Arlington, VA.
    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 number 
[OPP-300448]. 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: 
Sixth Floor, Crystal Station #1, 2800 Jefferson Davis Highway, 
Arlington, VA 22202. (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 potatoes and sugar beet roots at 0.05 part per 
million (ppm) and in or on sugar beet tops at 0.1 ppm. These tolerances 
will expire and be revoked automatically without further action by EPA 
on October 15, 1997.

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 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. 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 CFR 58135, 11/13/96).
    New 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.'' 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. 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.
    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. Section 408(l)(6) also requires EPA to promulgate regulations 
by August 3, 1997, governing the establishment of tolerances and 
exemptions under section 408(l)(6) and requires that the regulations be 
consistent with section 408(b)(2) and (c)(2) and FIFRA section 18.
    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 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 section 408(l)(6) procedural 
regulation and before EPA makes its broad policy decisions concerning 
the interpretation and implementation of the new section 408, EPA does 
not intend to set precedents for the application of 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 Potatoes and Sugar 
beets and FFDCA Tolerances

    On August 5, 1996, the Idaho Department of Agriculture availed 
itself of the authority to declare the existence

[[Page 1290]]

of a crisis situation within the state, thereby authorizing use under 
FIFRA section 18 of zinc phosphide on potatoes and sugar beets for 
control of meadow voles and field mice. Potato and sugarbeet growers in 
Idaho have experienced substantial losses in recent years due to vole 
and mouse damage. The only registered option available to sugarbeet and 
potato growers in Idaho is to use zinc phosphide on non-crop land 
surrounding their fields. Where fields are surrounded by other crops or 
bare ground, there are no registered controls or other effective non-
chemical methods.
    As part of its assessment of this crisis exemption, EPA assessed 
the potential risks presented by residues of phosphine on potatoes and 
sugar beets. In doing so, EPA considered the new safety standard in 
FFDCA section 408(b)(2), and EPA decided that the necessary tolerance 
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 potatoes and sugar 
beets treated in accordance with the provisions of the section 18 
emergency exemptions. Consistent with the need to move quickly on the 
emergency exemptions and to ensure that the resulting food is safe and 
lawful, EPA is issuing these tolerances without notice and opportunity 
for public comment under section 408(e) as provided in section 
408(l)(6). Although these tolerances will expire and be revoked 
automatically without further action by EPA on October 15, 1997, under 
FFDCA section 408(l)(5), residues of phosphine not in excess of the 
amount specified in these tolerances remaining in or on potatoes and 
sugar beet roots and tops 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 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 
potatoes or sugar beets or whether permanent tolerances for zinc 
phosphide for potatoes, or sugar beet roots or tops 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 Idaho to use this product on these crops under 
section 18 of FIFRA without following all provisions of section 18 as 
identified in 40 CFR part 166. For additional information regarding the 
emergency exemptions for zinc phosphide, contact the Agency's 
Registration Division at the address provided above.

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, which 
provides a dose that causes adverse effects (threshold effects) and 
doses causing no observed effects (the ``no-observed effect level'' or 
``NOEL'').
    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 percent 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 percent 
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 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. EPA has also 
assessed the toxicology data base for zinc phosphide in its evaluation 
of an application for a regional registration on sugarbeets. 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

[[Page 1291]]

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 percent of the bound phosphate residues in 
treated commodities as consisting of oxy-acids of phosphorus, which are 
considered toxicologically insignificant at the levels found in treated 
commodities. Data have since been submitted which demonstrate that the 
remaining 30 percent 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 section 408(b)(2), for the time-limited tolerances for 
residues of phosphine resulting from the use of zinc phosphide in or on 
potatoes and sugar beet roots at 0.05 ppm and in or on sugar beet tops 
at 0.1 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, 
the Office of Pesticide Programs (OPP) has established the RfD for zinc 
phosphide at 0.0003 milligrams(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.
    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 
percent zinc phosphide tracking powder has been classified in Toxicity 
Category IV (LC50 >19.6 mg/L), inhalation exposure resulting from this 
section 18 action is not considered toxicologically significant. For 
short-term and intermediate dermal MOE calculations, the Health Effects 
Division (HED), of 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, as there are no adequate carcinogenicity studies in 
rodents available in the toxicology data base. 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

    Tolerances are 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 (paragraph (a)(3) of 
40 CFR 180.6). Any residues of zinc phosphide ingested by livestock 
would be metabolized to naturally occurring phosphorous compounds.
    For the purpose of assessing chronic dietary exposure from zinc 
phosphide, EPA assumed tolerance level residues and 100 percent of crop 
treated for the proposed and existing food uses of zinc phosphide. 
These conservative assumptions result in overestimation of human 
dietary exposures.
    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 EFED One-Liner 
Data Base. There is no established Maximum Concentration Level (M.C.L.) 
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.
    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.
    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

    Taking into account the completeness and reliability of the 
toxicity data, EPA has concluded that dietary exposure to zinc 
phosphide will utilize 27.5 percent of the RfD for the U.S. population. 
EPA does not anticipate chronic exposure to residues of zinc phosphide 
(phosphine) in drinking water. EPA concludes that there is a reasonable 
certainty that no harm will result from aggregate exposure to zinc 
phosphide residues.

D. Determination of Safety for Infants and Children

    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 pre-natal sensitivities for infants and 
children. Since there are no

[[Page 1292]]

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.
    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 percent for nursing infants (<1 year old) up to 59.9 percent 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, EPA does not expect chronic exposure from drinking water. EPA 
therefore concludes that there is a reasonable certainty that no harm 
will result to infants and children from aggregate exposure to zinc 
phosphide.

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 
phoshine gas are described in PAM, Vol. II, as Method A.

VI. Conclusion

    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 potatoes and sugar beet 
roots at 0.05 ppm and sugar beet tops at 0.1 ppm. These tolerances will 
expire and be automatically revoked without further action by EPA on 
October 15, 1997.

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 section 408(e) and (l)(6) as was provided in the old section 408 
and in 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 March 10, 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 above (40 CFR 178.20). A copy of the objections 
and/or hearing requests filed with the Hearing Clerk should be 
submitted to the OPP docket for this rulemaking. The objections 
submitted must specify the provisions of the regulation deemed 
objectionable and the grounds for the objections (40 CFR 178.25). Each 
objection must be accompanied by the fee prescribed by 40 CFR 
180.33(i). If a hearing is requested, the objections must include a 
statement of the factual 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 Docket

    EPA has established a record for this rulemaking under docket 
number [OPP-300448] (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4:00 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.
    Electronic comments may be sent directly to EPA at:
    [email protected].

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer any copies of objections and hearing requests 
received electronically into printed, paper form as they are received 
and will place the paper copies in the official rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
address in ``ADDRESSES'' at the beginning of this document.

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).
    Because FFDCA section 408(l)(6) permits establishment of this 
regulation without a notice of proposed rulemaking, the regulatory 
flexibility analysis requirements of the Regulatory Flexibility Act, 5 
U.S.C. 604(a), do not apply.
    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

[[Page 1293]]

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'' as defined 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: January 2, 1997.

Daniel M. Barolo,

Director, Office of Pesticide Programs.
    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, by adding a new paragraph (c) to read as 
follows:


Sec. 180.284  Zinc phosphide; tolerances for residues.

*    *    *    *    *
    (c) Time-limited tolerances are established for residues of the 
phosphine resulting from the use of the rodenticide zinc phosphide in 
connection with use of the pesticide under section 18 emergency 
exemptions granted by EPA. The tolerances are specified in the 
following table. The tolerances expire and are automatically revoked on 
the date specified in the table without further action by EPA.

------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    Revocation Date 
------------------------------------------------------------------------
Potatoes........................  0.05                October 15, 1997  
Sugar beet (roots)..............  0.05                October 15, 1997  
Sugar beet (tops)...............  0.1                 October 15, 1997  
------------------------------------------------------------------------

[FR Doc. 97-512 Filed 1-8-97; 8:45 am]
BILLING CODE 6560-50-F