Zinc Phosphide; Pesticide Tolerances for Emergency Exemptions

Note: EPA no longer updates this information, but it may be useful as a reference or resource.
 [Federal Register: August 16, 2000 (Volume 65, Number 159)]
[Rules and Regulations]
[Page 49936-49941]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16au00-16]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301029; FRL-6598-9]
RIN 2070-AB


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 barley and wheat grain, hay and straw and wheat
aspirated grain fractions. This action is in response to EPA's

[[Page 49937]]

granting of emergency exemptions under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act authorizing use of the
pesticide on barley and wheat. This regulation establishes maximum
permissible levels for residues of phosphine in these food commodities.
The tolerances will expire and are revoked on December 31, 2001.

DATES: This regulation is effective August 16, 2000. Objections and
requests for hearings, identified by docket control number OPP-301029,
must be received by EPA on or before October 16, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301029 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: 703 308-9364; and e-mail address:
pemberton.libby@epa.gov.

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.
Potentially affected categories and entities may include, but are not
limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
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 Additional Information, Including Copies of this
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for
this action under docket control number OPP-301029. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(l)(6)
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is
establishing tolerances for residues of phosphine resulting from the
use of the rodenticide zinc phosphide in or on barley and wheat grain,
wheat hay and aspirated grain fractions at 0.010 parts per million
(ppm), barley hay at 0.20 ppm, and barley straw at 0.020 ppm. These
tolerances will expire and are revoked on December 31, 2001. EPA will
publish a document in the Federal Register to remove the revoked
tolerances from the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA 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. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18-related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
    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) 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)
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 the Federal Insecticide, Fungicide, and Rodenticide
Act (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
the Food Quality Protection Act (FQPA). EPA has established regulations
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemptions for Zinc Phosphide on Barley and Wheat
and FFDCA Tolerances

    EPA has authorized under FIFRA section 18 the use of zinc phosphide
on barley and wheat for control of meadow voles and field mice in
Idaho. After having reviewed the submission, EPA concurs that emergency
conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of zinc phosphide in or on
barley and wheat grain, hay and straw and wheat aspirated grain
fractions. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be

[[Page 49938]]

consistent with the safety standard and with FIFRA section 18.
Consistent with the need to move quickly on the emergency exemption in
order to address an urgent non-routine situation and to ensure that the
resulting food is safe and lawful, EPA is issuing this tolerance
without notice and opportunity for public comment as provided in
section 408(l)(6). Although this tolerance will expire and is revoked
on December 31, 2001, under FFDCA section 408(l)(5), residues of the
pesticide not in excess of the amounts specified in the tolerance
remaining in or on barley and wheat grain, hay and straw and wheat
aspirated grain fractions after that date will not be unlawful,
provided the pesticide is applied in a manner that was lawful under
FIFRA, and the residues do not exceed a level that was authorized by
this tolerance at the time of that application. EPA will take action to
revoke this tolerance earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
    Because this tolerance is being approved under emergency
conditions, EPA has not made any decisions about whether zinc phosphide
meets EPA's registration requirements for use on barley and wheat or
whether permanent tolerances for this use would be appropriate. Under
these circumstances, EPA does not believe that these tolerances serve
as a basis for registration of zinc phosphide by a State for special
local needs under FIFRA section 24(c). Nor do these tolerances serve as
the basis for any State other than Idaho to use this pesticide on this
crop under section 18 of FIFRA without following all provisions of
EPA's regulations implementing 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 provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    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 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) .
    Consistent with section 408(b)(2)(D), 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 zinc
phosphide and to make a determination on aggregate exposure, consistent
with section 408(b)(2), for time-limited tolerances for residues of
phosphine resulting from the use of the rodenticide zinc phosphide in
or on barley and wheat grain, wheat hay and aspirated grain fractions
at 0.010 ppm, barley hay at 0.20 ppm, and barley straw at 0.020 part
per million (ppm). EPA's assessment of the dietary exposures and risks
associated with establishing the tolerances follow.

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 this unit.

B. Toxicological Endpoint

    1. Acute toxicity. No toxicology studies were identified by EPA
which demonstrated the need for an acute dietary risk assessment.
    2. Short- and intermediate-term toxicity. Based on the acute dermal
LD50 study in rabbits, no appropriate toxic effects were
identified for risk assessment. In that study no mortalities were
observed at 5,000 milligrams/kilograms (mg/kg). At the lowest observed
adverse effect level (LOAEL) of 2,000 mg/kg, there was a decrease in
body weight. Based on the physical properties of the chemical, dermal
absorption is expected to be very low, since zinc phosphide reacts with
water and stomach acid to produce the toxic gas phosphine from oral,
but not dermal, exposure. As no endpoint of toxicological concern for
dermal exposure has been identified, no dermal penetration data were
required. The requirement for an acute inhalation study has been
waived, thus, zinc phosphide has been placed in Toxicity Category I for
acute inhalation exposure.
    3.Chronic toxicity. EPA has established the Reference Dose (RfD)
for zinc phosphide at 0.0001 mg/kg/day. This RfD is based on a
subchronic oral study in rats with a no observed adverse effect level
(NOAEL) of 0.1 mg/kg/day and an uncertainty factor of 1,000 based on
increased mortality, increase in absolute and relative liver weight and
hematological changes at the LOAEL of 1 mg/kg/day. An uncertainty
factor of 100 was applied to account for both the interspecies
extrapolation and intraspecies variability. An additional UF of 10 was
applied to account for the lack of reproductive data, and the lack of
chronic toxicity data in a non-rodent species.
    4. Carcinogenicity. Zinc phosphide has not been classified as to
its carcinogenic potential since cancer studies have been waived.
Although this chemical has food uses, dietary exposure is expected to
be minimal.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40
CFR 180.284) for the residues of phosphine resulting from the use of
zinc phosphide, in or on a variety of raw agricultural commodities at
levels ranging from 0.01 ppm in or on grapes to 0.1 ppm in or on
grasses (rangeland). There is no reasonable expectation of secondary
residues in meat, milk, poultry or eggs. Any residues of zinc phosphide
ingested by livestock would be metabolized to naturally occurring
phosphorous compounds. Risk assessments were conducted by EPA to assess
dietary exposures and risks from zinc phosphide as follows:
    Acute and chronic exposure and risk. Acute dietary risk assessments
are performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a 1-day or single exposure. In our best scientific judgment, the
proposed use of zinc phosphide on wheat and barley will not result in
acute or chronic human dietary exposure to zinc phosphide due to the
following:
    Zinc phosphide is not systemic.
    Applications are made prior to the grain head formation.
    Residue data show that residues of phosphine are less than the
limit of quantification (0.010 ppm) in wheat and barley grain.
    The grain will be highly processed prior to human consumption.
    There is no expectation of secondary residues in meat, milk,
poultry, and eggs as a result of the registered and proposed uses.
    2. From drinking water. Zinc phosphide degrades rapidly to
phosphine (PH3) and zinc ions (Zn²⁺), both of
which adsorb strongly to soil and are common nutrients in soil. Zinc
phosphide and its degradation products appear to have low potential for
ground and surface water contamination. Therefore, dietary exposure is
not expected from either ground or surface water fed drinking water.

[[Page 49939]]

    3. From non-dietary exposure. Zinc phosphide is currently
registered for use on residential non-food sites. A detailed
residential exposure assessment is contained in the RED for zinc
phosphide (RED Zinc Phosphide, EPA 738-R-98-006, July 1998). The
residential exposure assessment evaluated exposure from accidental
ingestion of zinc phosphide. No other residential exposure assessment
was required. It is stated in the RED that the Agency believes that
``accidental ingestion'' of zinc phosphide baits should not be included
in the FQPA determination for tolerance setting.
    4. Cumulative exposure to substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'' Zinc phosphide, aluminum phosphide and
magnesium phosphide all generate phosphine gas.
    EPA does not have, at this time, available data to determine
whether zinc phosphide has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, 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 more 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 final rule for Bifenthrin Pesticide Tolerances (62 FR 62961,
November 26, 1997).

D. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute and chronic risk. There is no drinking water, residential,
nor dietary component to acute and chronic aggregate exposure to zinc
phosphide residues. Thus, acute and chronic aggregate exposure
assessments are not required.
    2. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure. No short- or intermediate-term dermal, oral or
inhalation toxicological endpoints were identified for zinc phosphide.
Thus, no short- or intermediate-term risk assessments are required.
    3. Aggregate cancer risk for U.S. population. Although zinc
phosphide is registered for use on food crops, no chronic toxicity or
carcinogenicity studies were required because chronic exposure to zinc
phosphide or its byproducts were considered to be negligible. Thus,
data are not available to classify zinc phosphide in terms of
carcinogenicity and a cancer risk assessment was not performed.
    4. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to zinc phosphide residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

    1. Acute and chronic risk. There is no drinking water, residential,
nor dietary component to acute and chronic aggregate exposure to zinc
phosphide residues. Thus, acute and chronic aggregate exposure
assessments are not required.
    2. Short- or intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential exposure. No short- or intermediate-term dermal, oral or
inhalation toxicological endpoints were identified for zinc phosphide.
Thus, no short- or intermediate-term risk assessments are required.
    3. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to zinc phosphide
residues.

V. Other Considerations

A. Metabolism in Plants and Animals

    The nature of the residue in plants is adequately understood. The
residue of concern is zinc phosphide measured as phosphine.
    There is no expectation of secondary residues in meat, milk,
poultry, and eggs as a result of the registered uses. Residues of zinc
phosphide ingested by livestock would be immediately converted to
phosphine and metabolized to naturally occurring phosphorous compounds.

B. Analytical Enforcement Methodology

    Adequate enforcement methodology (colorimetric and GLC/FPD) is
available (Pesticide Analytical Method II under aluminum phosphide) to
enforce the tolerance expression.

C. Magnitude of Residues

    Residues of phosphine resulting from the use of zinc phosphide are
not expected to exceed 0.010 ppm in/on barley grain and wheat grain,
0.20 ppm in barley hay, 0.020 ppm in barley straw, 0.010 ppm in wheat
hay, 0.010 ppm in wheat straw, 0.010 ppm in aspirated grain fractions
under the use conditions of this section 18 exemption.

D. International Residue Limits

    No CODEX, Canadian or Mexican Maximum Residue Levels have been
established for zinc phosphide.

E. Rotational Crop Restrictions

    Data for confined accumulation in rotational crops has been waived
because the physical properties of zinc phosphide precludes transfer of
residues to rotated crops (Zinc Phosphide RED, EPA 738-R-98-006, July
1998). Thus, rotational crop restrictions are not required.

VI. Conclusion

    Therefore, tolerances are established for residues of phosphine
resulting from the use of the rodenticide zinc phosphide in or on
barley and wheat grain, wheat hay and aspirated grain fractions at
0.010 ppm, barley hay at 0.20 ppm, and barley straw at 0.020 ppm.

VII. 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 of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.

[[Page 49940]]

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 control number OPP-301029 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 October
16, 2000.
    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 (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. 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 (202) 260-4865.
    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 tompkins.jim@epa.gov,
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.
    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.
    3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.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.2. Mail your
copies, identified by the docket control number OPP-301029, 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.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 file format 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).

VIII. Regulatory Assessment Requirements

    This final rule establishes time-limited tolerances under FFDCA
section 408. 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).
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 prior consultation
as specified by Executive Order 13084, entitled Consultation and
Coordination with Indian Tribal Governments (63 FR 27655, May 19,
1998); special considerations as required by Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or require 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 FIFRA
section 18 petition under FFDCA section 408, such as the tolerances 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 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

[[Page 49941]]

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 FFDCA section 408(n)(4).

IX. Submission to Congress and the Comptroller General

    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: August 8, 2000.
James Jones,
Director, Registration Division, 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. 321(q), 346(a) and 371.
    2. Section 180.284 is amended by alphabetically adding the
following commodities to the table in paragraph (b) to read as follows:

Sec. 180.284  Zinc phosphide; tolerances for residues.

    *    *    *    *    *
    (b) *    *    *

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    Revocation
                                                  million        Date
------------------------------------------------------------------------

                  *        *        *        *        *
Barley, grain.................................        0.010     12/31/01
Barley, hay...................................         0.20     12/31/01
Barley, straw.................................        0.020     12/31/01

                  *        *        *        *        *
Wheat, aspirated grain fractions..............        0.010     12/31/01
Wheat, grain..................................        0.010     12/31/01
Wheat, hay....................................        0.010     12/31/01
Wheat, straw..................................        0.010     12/31/01
------------------------------------------------------------------------

    *    *    *    *    *
[FR Doc. 00-20731 Filed 8-15-00; 8:45 am]
BILLING CODE 6560-50-F
Zinc Phosphide; Pesticide Tolerances for Emergency Exemptions

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