[Federal Register Volume 63, Number 236 (Wednesday, December 9, 1998)]
[Rules and Regulations]
[Pages 67794-67799]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32574]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300760; FRL 6046-1]
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 a time-limited tolerance for
residues of phosphine in or on potatoes, sugar beet (roots), and sugar
beet (tops). This action is in response to EPA's granting of an
emergency exemption under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act authorizing use of the pesticide on
potatoes and sugarbeets. This regulation establishes a maximum
permissible level for residues of phosphine in these food commodities
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 are revoked on May 1, 2000.
DATES: This regulation is effective December 9, 1998. Objections and
requests for hearings must be received by EPA on or before February 8,
1999.
[[Page 67795]]
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300760], 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 docket
control number, [OPP-300760], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), 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. 119, Crystal
Mall #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: opp-docket@epamail.epa.gov. 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 5.1/6.1
or ASCII file format. All copies of objections and hearing requests in
electronic form must be identified by the docket control number [OPP-
300760]. 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 (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location, telephone number, and e-mail address: Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA, (703) 308-9364; e-mail:
pemberton.libby@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
sections 408(e) and (l)(6) of the FFDCA, 21 U.S.C. 346a(e) and (l)(6),
is establishing tolerances for residues of the rodenticide zinc
phosphide, in or on potatoes and sugar beets at 0.05 part per million
(ppm). These tolerances will expire and are revoked on May 1, 2000. EPA
will publish a document in the Federal Register to remove the revoked
tolerances from the Code of Federal Regulations.
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 FR 58135, November 13, 1996) (FRL 5572-9).
New 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 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) 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.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
II. Emergency Exemption for Zinc Phosphide on Potatoes and Sugar
beets and FFDCA Tolerances
Potato and sugar beet growers in Idaho have experienced substantial
losses in recent years due to vole and mouse damage. The only
registered option available to sugar beet 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. EPA has
authorized under FIFRA section 18 the use of zinc phosphide on potatoes
and sugar beets for control of voles and 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 phosphine in or on
potatoes and sugar beets. 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 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 under section 408(e), as provided in section
408(l)(6). Although this tolerance will expire and is revoked on May 1,
2000, under FFDCA section 408(l)(5), residues of the pesticide not in
excess of the amounts specified in the tolerance remaining in or on
potatoes and sugar beets 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
[[Page 67796]]
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 potatoes and sugar beets 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 does this tolerance 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 above.
III. 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 phosphine
and to make a determination on aggregate exposure, consistent with
section 408(b)(2), for a time-limited tolerance for residues of zinc
phosphide on potatoes and sugar beet (roots) at 0.05 ppm and sugar beet
(tops) at 0.1 ppm. EPA's assessment of the dietary exposures and risks
associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by zinc phosphide are
discussed below.
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 non-dietary 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 milligram/kilogram mg/kg. At the
lowest observed effect level (LOEL) 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 RfD for zinc phosphide
at 0.001 (mg/kg/day). However, as indicated in the Reregistration
Eligibility Document (RED), a chronic dietary risk assessment is not
required because exposure from food sources is expected to be minimal
to non-existent. There are no detectable residues in potatoes.
Furthermore potatoes are often washed and cooked before they are eaten
thereby further reducing any trace of residues. Residue studies showed
there were detectable residues in sugar beet roots and tops; however,
these commodities are not direct human foods and no dietary consumption
is expected. Sugar beet tops are fed to livestock; however, there is no
likelihood of residues of zinc phosphide being found through transfer
of residues to meat and milk. Residues of zinc phosphide ingested by
livestock would be immediately converted to phosphine and metabolized
to naturally occurring phosphorus compounds. Furthermore, the Agency
believes that the refining process for sugar beets will remove any
unreacted zinc phosphide from refined sugar and the data requirements
for a sugar beet processing study has been waived. Therefore the Agency
has determined that there is no likelihood of residues of zinc
phosphide occurring in any processed commodities and no chronic dietary
exposure assessment is required.
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.
B. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.284) for the residues of zinc phosphide, in or on a variety of
raw agricultural commodities. Risk assessments were conducted by EPA to
assess dietary exposures and risks from zinc phosphide as follows:
i. Acute 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 one day or single exposure. Acute dietary endpoints were not
identified; thus an acute dietary risk assessment was not performed.
ii. Chronic exposure and risk. For the purpose of assessing chronic
dietary exposure to zinc phosphide from food, EPA assumed tolerance
level residues and 100% of crop treated for potatoes, sugarbeets and
all other commodities having zinc phosphide tolerances. These
conservative assumptions result in over estimation of human dietary
exposures.
2. From drinking water. The EPA Safe Drinking Water Hotline has
indicated (06/97) that there are no established maximum contaminant
levels (MCL) for residues of zinc phosphide in drinking water. No
health advisory levels for zinc phosphide in drinking water have been
established. There is no entry for zinc phosphide in the ``Pesticides
in Groundwater Database'' (EPA 734-12-92-001, September 1992).
Furthermore as indicated in the RED, zinc phosphide and its degradation
products appear to have a low potential for ground water or surface
water contamination. Therefore, dietary exposure is not expected from
either ground or surface water fed drinking water and a drinking water
risk assessment was not performed in the RED. Since the issuance of the
RED, drinking water levels of comparison (DWLOCs) for zinc phosphide
were calculated in accordance with the current Standard Operating
Procedures for Drinking Water Exposure and Risk Assessments. The Agency
concludes with reasonable certainty that exposure to zinc phosphide in
drinking water would not result in unacceptable levels of concern.
i. Acute exposure and risk. Acute dietary endpoints have not been
identified; therefore, a DWLOC for acute dietary exposure was not
determined.
ii. Chronic exposure and risk. Zinc phosphide degrades rapidly to
Zn2+ and PH3, which sorb strongly to soil and are
common nutrients in soil. Zinc
[[Page 67797]]
phosphide and its degradation products appear to have a low potential
for ground water or surface water contamination. Therefore, EPA
concludes with reasonable certainty that the residues of zinc phosphide
in drinking water would not result in unacceptable levels of concern.
3. From non-dietary exposure. Zinc phosphide is currently
registered for use on the following residential non-food sites: hand-
applied bait to underground burrows in/on the following sites/settings:
bulb crops, golf course turfgrass, lawns, ornamentals, nurseries,
parks, homes, industrial, commercial, and agricultural buildings.
Because of these residential uses, EPA has concerns about possible
post-application exposures to children. A post-application exposure and
risk assessment, using the method described in the draft Standard
Operating Procedures (SOPs) for Residential Exposure Assessments was
conducted. The margin of exposure (MOE) of 310 for post-application
exposure to children at residential sites does not exceed EPA's level
of concern (i.e., acceptable MOEs are 100). The dose
estimates generated here are based on some central tendency (i.e., body
weight) and some upper-percentile assumptions (i.e., ingestion rate of
dry pesticide formulation, and maximum application rate) and are
considered to be representative of high-end exposure. The uncertainties
associated with this assessment stem from the use of an assumed
ingestion rate of dry pesticide formulation. The dose estimates are
considered to be reasonable high-end estimates based on professional
judgement.
4. Cumulative exposure to substances with 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.''
Although zinc phosphide may share a common mode of toxicity (the
generation of phosphine gas) with other chemicals (aluminum and
magnesium phosphide), the Agency has determined that any future
cumulative risk determination involvling these chemicals will not
include the current uses of zinc phosphide. This determination is based
on the fact that exposures to phosphine from zinc phosphide in food or
water are negligible due to zinc phosphide's rapid degradation and
limited use patterns.
C. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. Acute dietary endpoints were not identified; thus an
acute dietary risk assessment was not performed.
2. Chronic risk. A chronic dietary reference dose (RfD) was
established for zinc phosphide at 0.0001 mg/kg/day (see Zinc Phosphide
RED, 7/98). However, as indicated in the RED, a chronic dietary risk
assessment is not required because exposure from food sources is
expected to be minimal to non-existent. There are no detectable
residues in potatoes. Furthermore potatoes are often washed and cooked
before they are eaten thereby further reducing any trace of residues.
Residue studies showed there were detectable residues in sugar beet
(roots) and (tops); however, these commodities are not direct human
foods and no dietary consumption is expected. Sugar beet (tops) are
feed to livestock; however, there is no likelihood of residues of zinc
phosphide being found through transfer of residues to meat and milk.
Residues of zinc phosphide ingested by livestock would be immediately
converted to phosphine and metabolized to naturally occurring
phosphorus compounds. Furthermore, the Agency believes that the
refining process or sugar beets will remove any unreacted zinc
phosphide from refined sugar and the data requirements for a sugar beet
processing study has been waived. Therefore the Agency has determined
that there is no likelihood of residue of zinc phosphide occurring in
any processed commodities and no chronic dietary exposure assessment is
required.
3. 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. A short and intermediate term aggregate risk
assessment is not required as a non-dietary endpoint was not
identified.
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.
D. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children -- i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of zinc phosphide, EPA considered data from
developmental toxicity studies in the rat. The developmental toxicity
studies are designed to evaluate adverse effects on the developing
organism resulting from maternal pesticide exposure during gestation.
Reproduction studies provide information relating to effects from
exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre-and post-natal toxicity and the
completeness of the database unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a MOE analysis or through using uncertainty (safety)
factors in calculating a dose level that poses no appreciable risk to
humans. EPA believes that reliable data support using the standard 100-
fold factor (usually 100 for combined inter- and intra-species
variability) and not the additional tenfold safety factor when EPA has
a complete data base under existing guidelines and when the severity of
the effect in infants or children or the potency or unusual toxic
properties of a compound do not raise concerns regarding the adequacy
of the standard MOE/safety factor.
ii. Developmental toxicity studies. In the developmental study in
rats, the maternal no observed adverse effect level (NOAEL) was 2.0 mg/
kg/day, based on increased mortality at the LOEL of 4.0 mg/kg/day. The
developmental (fetal) NOAEL was 4.0 mg/kg/day, the highest dose tested.
iii. Pre- and post-natal sensitivity. The toxicological data base
for evaluating pre- and post-natal toxicity for zinc phosphide is not
complete. EPA is not requiring these studies because exposure from food
sources is expected to be insignificant. The rat developmental toxicity
data provided no indication of increased sensitivity of fetal rats to
in utero exposure to zinc phosphide. In that study, no developmental
effects were observed at the highest dose tested which was shown to be
maternally toxic. An additional uncertainty factor of 10 was applied to
the reference dose calculation to account for the extrapolation from
subchronic to chronic exposure, the lack of reproductive toxicity data,
and the lack of chronic toxicity data in a non-rodent species, this
additional uncertainty factor will accomodate the inability to assess
the potential for increased sensitivity of infants and children,
because of the lack of animal data.
[[Page 67798]]
2. 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.
IV. Other Considerations
A. Metabolism In Plants and Animals
The residue of concern is zinc phosphide per se, measured as
phosphine. There is no expectation of secondary residues in meat, milk,
poultry, and eggs as a result of the registered zinc phosphide uses .
B. Analytical Enforcement Methodology
Adequate analytical methodology (spectrophotometric) is available
in PAM II (Sec. 180.284, Method A) to enforce the tolerance expression.
The method determines zinc phosphide residues as phosphine gas.
C. Magnitude of Residues
Residues of phosphine resulting from the proposed use of zinc
phosphide are not expected to exceed 0.05 ppm in potatoes, 0.05 ppm in
sugar beet (roots), and 0.1 ppm in sugar beet (tops). Concentration of
residues in potato and sugar beet processing by-products is not
expected. There is no reasonable expectation of secondary residues in
meat, milk, poultry, or eggs.
D. International Residue Limits
No Codex, Canadian or Mexican Maximum Residue Levels have been
established for zinc phosphide.
V. Conclusion
Therefore, the tolerances are established for residues of zinc
phosphide in potatoes and sugar beet (roots) at 0.05 ppm and sugar beet
(tops) at 0.1 ppm.
VI. 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 February 8, 1999, file written objections to any
aspect of this regulation 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 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.
VII. Public Record and Electronic Submissions
EPA has established a record for this rulemaking under docket
control number [OPP-300760] (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 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C)
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:
opp-docket@epamail.epa.gov.
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
Virginia address in ``ADDRESSES'' at the beginning of this document.
VIII. Regulatory Assessment Requirements
A. Certain Acts and Executive Orders
This final rule establishes tolerances under FFDCA section 408
(l)(6). 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) (Pub. L. 104-4). Nor does it require any prior consultation as
specified by Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), or
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 in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In addition, since tolerances and exemptions that are established
under FFDCA section 408 (l)(6), 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. Nevertheless, the
[[Page 67799]]
Agency has previously assessed whether establishing tolerances,
exemptions from tolerances, raising tolerance levels or expanding
exemptions might adversely impact small entities and concluded, as a
generic matter, that there is no adverse economic impact. The factual
basis for the Agency's generic certification for tolerance acations
published on May 4, 1981 (46 FR 24950), and was provided to the Chief
Counsel for Advocacy of the Small Business Administration.
B. Executive Order 12875
Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local, or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.
C. Executive Order 13084
Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide to OMB, in a separately
identified section of the preamble to the rule, a description of the
extent of EPA's prior consultation with representatives of affected
tribal governments, a summary of the nature of their concerns, and a
statement supporting the need to issue the regulation. In addition,
Executive Order 13084 requires EPA to develop an effective process
permitting elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of section 3(b) of Executive Order 13084 do not apply to
this rule.
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 the rule in the Federal Register. This 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: November 24, 1998.
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. 346a and 371.
2. In Sec. 180.284, in paragraph (b), by alphabetically adding the
following commodities to the table to read as follows:
Sec. 180.284 Zinc phosphide; tolerances for residues.
* * * * *
(b) * * *
------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------
* * * * * * *
Potatoes........................ 0.05 5/1/00
* * * * * * *
Sugar beet (roots).............. 0.05 5/1/00
Sugar beet (tops)............... 0.1 5/1/00
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 98-32574 Filed 12-8-98; 8:45 am]
BILLING CODE 6560-50-F
