[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: 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 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:
pemberton.libby@epamail.epa.gov.
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:="">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
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
