[Federal Register Volume 62, Number 34 (Thursday, February 20, 1997)]
[Rules and Regulations]
[Pages 7679-7684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3931]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300453; FRL-5588-1]
RIN 2070-AB78
Zinc Phosphide; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
residues of phosphine resulting from the use of the rodenticide zinc
phosphide in or on the raw agricultural commodities timothy (seed,
forage, hay), alfalfa (forage, hay), and clover (forage, hay) in
connection with EPA's granting of an emergency exemption to the state
of Washington under section 18 of the Federal Insecticide, Fungicide,
and Rodenticide Act authorizing use of zinc phosphide on timothy or
timothy-alfalfa, clover stands. This regulation establishes maximum
permissible levels for residues of phosphine in these foods pursuant to
section 408(l)(6) of the Federal Food, Drug and Cosmetic Act, as
amended by the Food Quality Protection Act of 1996. The tolerances will
expire on April 15, 1998.
DATES: This regulation is effective February 20, 1997. The entries in
the table expire on April 15, 1998. Objections and requests for
hearings must be received by EPA on or before April 21, 1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300453], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Room M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300453], must also be submitted to: Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, bring a copy of
objections and hearing requests to: Crystal Mall #2, Room 1132, 1921
Jefferson Davis Highway, Arlington, VA.
[[Page 7680]]
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: 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 control
number [OPP-300453]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration
Division (7505W), Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location, telephone number, and e-mail
address: Sixth Floor, Crystal Station #1, 2800 Jefferson Davis Highway,
Arlington, VA, 703-308-8326, e-mail: 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 timothy (seed, forage, hay), alfalfa (forage,
hay), and clover (forage, hay) at 0.1 part per million (ppm). These
tolerances will expire and be revoked automatically without further
action by EPA on April 15, 1998.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the FFDCA, 21
U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. The FQPA amendments went
into effect immediately. Among other things, FQPA amends FFDCA to bring
all EPA pesticide tolerance-setting activities under a new section 408
with a new safety standard and new procedures. These activities are
described below and discussed in greater detail in the final rule
establishing the time-limited tolerance associated with the emergency
exemption for use of propiconazole on sorghum (61 FR 58135, November
13, 1996, FRL-5572-9).
New FFDCA section 408(b)(2)(A)(i) allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' FFCDA
section 408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water, but does
not include occupational exposure. FFDCA section 408(b)(2)(C) requires
EPA to give special consideration to exposure of infants and children
to the pesticide chemical residue in establishing a tolerance and to
``ensure that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to the pesticide
chemical residue....''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
FFDCA section 408(l)(6) requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. FFDCA section 408(l)(6) also requires EPA to promulgate
regulations by August 3, 1997, governing the establishment of
tolerances and exemptions under FFDCA section 408(l)(6) and requires
that the regulations be consistent with FFDCA section 408(b)(2) and
(c)(2) and FIFRA section 18.
FFDCA section 408(l)(6) allows EPA to establish tolerances or
exemptions from the requirement for a tolerance, in connection with
EPA's granting of FIFRA section 18 emergency exemptions, without
providing notice or a period for public comment. Thus, consistent with
the need to act expeditiously on requests for emergency exemptions
under FIFRA, EPA can establish such tolerances or exemptions under the
authority of FFDCA section 408(e) and (l)(6) without notice and comment
rulemaking.
In establishing section 18-related tolerances and exemptions during
this interim period before EPA issues the FFDCA section 408(l)(6)
procedural regulation and before EPA makes its broad policy decisions
concerning the interpretation and implementation of the new FFDCA
section 408, EPA does not intend to set precedents for the application
of FFDCA section 408 and the new safety standard to other tolerances
and exemptions. Rather, these early section 18 tolerance and exemption
decisions will be made on a case-by-case basis and will not bind EPA as
it proceeds with further rulemaking and policy development. EPA intends
to act on section 18-related tolerances and exemptions that clearly
qualify under the new law.
II. Emergency Exemptions for Zinc Phosphide on Timothy and Timothy-
alfalfa/clover and FFDCA Tolerances
EPA has authorized use under FIFRA section 18 of zinc phosphide on
timothy and timothy-alfalfa/clover for control of the vole complex. A
potential population of 500 voles per acre would mean significant
economic loss during 1997. The currently available methods of control,
including the use of zinc phosphide bait boxes and flood irrigation,
are inadequate and impractical.
As part of its assessment of this specific exemption, EPA assessed
the potential risks presented by residues of phosphine on timothy
(seed, forage, hay), alfalfa (forage, hay), and clover (forage, hay).
In doing so, EPA considered the new safety standard in FFDCA section
408(b)(2), and EPA decided that the necessary tolerances under FFDCA
section 408(l)(6) would clearly be consistent with the new safety
standard and with FIFRA section 18. These tolerances for residues of
phosphine will permit the marketing of timothy and timothy-alfalfa/
clover treated in accordance with the provisions of the FIFRA section
18-emergency exemptions. Consistent with the need to move quickly on
this emergency exemption and in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing these tolerances without notice and opportunity for public
comment under FFDCA section 408(e) as provided in FFDCA section
408(l)(6). Although these tolerances will expire and be revoked
automatically without further action by EPA on April 15, 1998, under
FFDCA section 408(l)(5), residues of phosphine not in excess of the
amount specified in these tolerances remaining in or on timothy (seed,
forage, hay), alfalfa (forage, hay), and clover (forage, hay) after
that date will not be unlawful, provided the pesticide is applied
during the term of, and in accordance with all the conditions of, the
emergency exemptions. EPA will take action to revoke these tolerances
earlier if any experience with, scientific data on, or
[[Page 7681]]
other relevant information on this pesticide indicate that the residues
are not safe.
EPA has not made any decisions about whether zinc phosphide meets
the requirements for registration under FIFRA section 3 for use on
timothy and timothy-alfalfa/clover or whether permanent tolerances for
zinc phosphide for timothy (seed, forage, hay), alfalfa (forage, hay),
and clover (forage, hay) would be appropriate. This action by EPA does
not serve as a basis for registration of zinc phosphide by a State for
special local needs under FIFRA section 24(c). Nor does this action
serve as the basis for any States other than Washington to use this
product on these crops under FIFRA section 18 without following all
provisions of FIFRA section 18 as identified in 40 CFR part 166. For
additional information regarding the emergency exemption for zinc
phosphide, contact the Agency's Registration Division at the address in
``ADDRESSES'' at the beginning of this document.
III. Risk Assessment and Statutory Findings
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. For many
of these studies, a dose response relationship can be determined, by
using a dose that causes adverse effects (threshold effects) and a dose
that causes no observed effect levels (NOELs).
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the reference dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals and that one person or subgroup of the population (such as
infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100% or less of the RfD) is
generally considered acceptable by EPA.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low-dose
extrapolations or margin of exposure (MOE) calculation based on the
appropriate NOEL) will be carried out based on the nature of the
carcinogenic response and the Agency's knowledge of its mode of action.
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, and other non-
occupational exposures, such as where residues leach into groundwater
or surface water that is consumed as drinking water. Dietary exposure
to residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The theoretical maximum residue contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. The TMRC is a
``worst case'' estimate since it is based on the assumptions that food
contains pesticide residues at the tolerance level and that 100% of the
crop is treated by pesticides that have established tolerances. If the
TMRC exceeds the RfD or poses a lifetime cancer risk that is greater
than approximately one in a million, EPA attempts to derive a more
accurate exposure estimate for the pesticide by evaluating additional
types of information (anticipated residue data and/or percent of crop
treated data) which show, generally, that pesticide residues in most
foods when they are eaten are well below established tolerances.
IV. Aggregate Risk Assessment and Determination of Safety
Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. Zinc phosphide is already registered by EPA for outdoor
residential lawn, nursery, right-of-way, recreational area, and other
non-food uses, as well as several food use registrations. Phosphine is
a highly reactive gas that reacts with raw agricultural commodities to
form bound phosphate residues. The Agency stated in a registration
standard for zinc phosphide (June 23, 1982) that a tolerance of 0.1 ppm
for phosphine resulting from the use of zinc phosphide would be
allowable for raw agricultural commodities, provided the bound
phosphate residues can be fully characterized. At the time the
registration standard was issued, the Agency identified 70% of the
bound phosphate residues in treated commodities as consisting of
oxyphosphorus acids, which are considered toxicologically insignificant
at the levels found in treated commodities. Data have since been
submitted which demonstrate that the remaining 30% of residues consists
of oxidation products of phosphine (oxyphosphorus acids and/or their
salts), which are also considered toxicologically insignificant at the
levels found in treated commodities. EPA believes it has sufficient
data to assess the hazards of zinc phosphide and to make a
determination on aggregate exposure, consistent with FFDCA section
408(b)(2), for the time-limited tolerances for residues of phosphine
resulting from the use of zinc phosphide in or on timothy (seed,
forage, hay), alfalfa (forage, hay), and clover (forage, hay) at 0.1
part per million (ppm). EPA's assessment of the dietary exposures and
risks associated with establishing these tolerances follows.
A. Toxicological Profile
1. Chronic toxicity. Based on the available chronic toxicity data,
EPA's Office of Pesticide Programs (OPP) has established the RfD for
zinc phosphide at 0.0003 milligram(mg)/kilogram(kg)/day. The RfD was
established based on an lowest effect level (LEL) of 3.48 mg/kg/day
from an open literature 90-day rat feeding study. Effects observed at
the LEL were decreased food consumption and body weight. An uncertainty
factor of 10,000 was used due to data gaps and the absence of a NOEL in
the study. The Agency has recently reviewed a 90-day gavage study in
rats which had a NOEL
[[Page 7682]]
of 0.1 mg/kg/day and a LEL of 1.0 mg/kg/day. The LEL of 1.0 mg/kg/day
was based on increased mortality and kidney nephrosis in male rats.
2. Acute toxicity. No toxicology studies were identified by OPP
which demonstrated the need for an acute dietary risk assessment.
3. Short-term, non-dietary inhalation and dermal toxicity. Since
10% zinc phosphide tracking powder has been classified in Toxicity
Category IV (LC50 > 19.6 mg/liter (L)), inhalation exposure
resulting from this FIFRA section 18 action is not considered
toxicologically significant. For short-term and intermediate dermal MOE
calculations, EPA's Health Effects Division (HED), OPP recommended use
of the adjusted acute dermal LD50 NOEL of 1,000 mg/kg from the
acute dermal toxicity study in rabbits. In the absence of other dermal
toxicity data, the acute NOEL dose of 1,000 mg/kg was divided by a 100-
fold uncertainty factor to approximate a 3-month dermal NOEL for worker
dermal exposure. The 3-month dermal NOEL is 10 mg/kg/day. At the LEL of
2,000 mg/kg in the rabbit dermal LD50 study, the animals lost
weight, but no mortalities were observed up to 5,000 mg/kg highest dose
tested (HDT). Actual risk from dermal exposure is likely to be
significantly less, since zinc phosphide reacts with water and stomach
acid to produce the toxic gas phosphine from oral, but not dermal,
exposure.
4. Carcinogenicity. Zinc phosphide has not been reviewed for
carcinogenicity. OPP has waived carcinogenicity data requirements for
zinc phosphide on the basis that exposures to zinc phosphide are
controlled to prevent exposures to humans. Applications to crop areas
are such that the zinc phosphide will dissipate.
B. Aggregate Exposure
1. Tolerances are already established for residues of the phosphine
resulting from the use of zinc phosphide on several raw agricultural
commodities (40 CFR 180.284 (a) and (b)). There is no reasonable
expectation of secondary residues in meat, milk, poultry, or eggs (40
CFR 180.6(a)(3)). Any residues of zinc phosphide ingested by livestock
would be metabolized to naturally occurring phosphorous compounds. No
human food items are derived from timothy grown for seed or mixed
stands of timothy-alfalfa/clover produced for hay. Therefore, humans
will receive no additional dietary exposure to phosphine as a result of
establishment of this tolerance.
2. For the purpose of assessing chronic dietary exposure from zinc
phosphide, EPA assumed tolerance level residues and 100% of crop
treated for the proposed and existing food uses of zinc phosphide.
These conservative assumptions result in over estimation of human
dietary exposures.
3. Other potential sources of exposure of the general population to
residues of pesticides are residues in drinking water and exposure from
non-occupational sources. There is no information on zinc phosphide
(phosphine) residues in ground water and runoff in the EPA's
Environmental Fate and Effects Division (EFED) One-Liner Data Base.
There is no established maximum concentration level (MCL) for residues
of zinc phosphide (phosphine) in drinking water. No drinking water
health advisory levels have been established for zinc phosphide
(phosphine). There is no entry for zinc phosphide (phosphine) in the
``Pesticides in Groundwater Database'' (EPA 734-12-92-001, September
1992). Based on the available studies used in EPA's assessment of
environmental risk, EPA does not anticipate exposure to residues of
zinc phosphide (phosphine) in drinking water.
4. There are residential uses of zinc phosphide and EPA
acknowledges that there may be short-, intermediate-, and long-term
non-occupational, non-dietary exposure scenarios. OPP has identified a
toxicity endpoint for an intermediate-term residential risk assessment.
However, no acceptable reliable dermal exposure data to assess these
potential risks are available at this time. Given the time-limited
nature of this request, the need to make emergency exemption decisions
quickly, and the significant scientific uncertainty at this time about
how to aggregate non-occupational exposure with dietary exposure, the
Agency will make its safety determination for these tolerances based on
those factors which it can reasonably integrate into a risk assessment.
5. At this time, the Agency has not made a determination that zinc
phosphide and other substances that may have a common mode of toxicity
would have cumulative effects. Given the time-limited nature of this
request, the need to make emergency exemption decisions quickly, and
the significant scientific uncertainty at this time about how to define
common mode of toxicity, the Agency will make its safety determination
for these tolerances based on those factors which can reasonably
integrate into a risk assessment. For purposes of these tolerances
only, the Agency is considering only the potential risks of zinc
phosphide in its aggregate exposure.
C. Safety Determinations For U.S. Population
No human food items are derived from timothy grown for seed or
mixed stands of timothy-alfalfa/clover produced for hay. Taking into
account the completeness and reliability of the toxicity data, EPA has
concluded that dietary exposure to zinc phosphide from published
tolerances (including recently published time-limited tolerances for
potatoes and sugar beets) will utilize 27.5% of the RfD for the U.S.
population. EPA does not anticipate chronic exposure to residues of
zinc phosphide (phosphine) in drinking water.
D. Determination of Safety for Infants and Children
1. There were no developmental findings in rats up to a maternally
toxic dose of 4.0 mg/kg/day zinc phosphide nor in mice at 4.0 mg/kg/day
HDT. A comparison of the NOEL of 0.1 mg/kg/day in the recent 90-day rat
gavage study and the NOELs for developmental toxicity in rats and mice
(4.0 mg/kg/day) provides a 40-fold difference, which demonstrates that
there are no special prenatal sensitivities for infants and children.
OPP has waived teratogenicity in the rabbit and the two-generation
reproduction study in the rat data requirements for zinc phosphide on
the basis that exposures to zinc phosphide are controlled to prevent
exposures to humans. Applications to crop areas are such that the zinc
phosphide will dissipate. Since there are no reproduction studies with
zinc phosphide, the post-natal potential for effects from zinc
phosphide in infants and children cannot be fully evaluated. However,
the above information, together with the uncertainty factor of 10,000
utilized to calculate the RfD for zinc phosphide, is considered
adequate protection for infants and children with respect to prenatal
and postnatal development against dietary exposure to zinc phosphide
residues, and therefore, EPA has determined that an additional 10-fold
safety factor is not appropriate.
2. EPA has concluded that the percent of the RfD that will be
utilized by chronic dietary exposure to residues of zinc phosphide
ranges from 6.8% for nursing infants (<1 year="" old)="" up="" to="" 59.9%="" for="" children="" 1="" to="" 6="" years="" old.="" however,="" this="" calculation="" assumes="" tolerance="" level="" residues="" for="" all="" commodities="" and="" is="" therefore="" an="" over="" estimate="" of="" dietary="" risk.="" refinement="" of="" the="" dietary="" risk="" assessment="" by="" using="" anticipated="" residue="" data="" would="" reduce="" dietary="" exposure.="" as="" mentioned="" before,="" [[page="" 7683]]="" epa="" does="" not="" expect="" chronic="" exposure="" from="" drinking="" water.="" v.="" other="" considerations="" the="" metabolism="" of="" zinc="" phosphide="" in="" plants="" and="" animals="" is="" adequately="" understood="" for="" the="" purposes="" of="" these="" tolerances.="" the="" residue="" of="" concern="" is="" unreacted="" zinc="" phosphide,="" measured="" as="" phosphine,="" that="" may="" be="" present.="" adequate="" methods="" for="" purposes="" of="" data="" collection="" and="" enforcement="" of="" tolerances="" for="" zinc="" phosphide="" residues="" as="" phosphine="" gas="" are="" available.="" methods="" for="" determining="" zinc="" phosphide="" residues="" of="" phosphine="" gas="" are="" described="" in="" pam,="" vol.="" ii,="" as="" method="" a.="" there="" are="" no="" codex="" tolerances="" for="" timothy="" (seed,="" forage,="" hay),="" alfalfa="" (forage,="" hay),="" and="" clover="" (forage,="" hay).="" vi.="" conclusion="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" of="" no="" harm="" to="" consumers,="" including="" infants="" and="" children,="" from="" aggregate="" exposure="" to="" zinc="" phosphide="" based="" on="" the="" following="" considerations.="" first,="" approval="" of="" these="" tolerances="" results="" in="" no="" additional="" exposure="" to="" consumers.="" second,="" epa="" has="" used="" a="" 10,000-fold="" safety="" factor="" in="" assessing="" the="" risk="" estimate="" posed="" by="" zinc="" phosphide.="" third,="" this="" pesticide="" is="" being="" used="" to="" address="" an="" emergency="" situation="" and="" epa,="" therefore,="" must="" make="" a="" quick="" decision.="" fourth,="" because="" these="" tolerances="" are="" for="" an="" emergency="" situation,="" extended="" use="" under="" these="" tolerances="" are="" not="" authorized.="" therefore,="" tolerances="" in="" connection="" with="" the="" fifra="" section="" 18="" emergency="" exemptions="" are="" established="" for="" residues="" of="" phosphine="" resulting="" from="" the="" use="" of="" zinc="" phosphide="" in="" timothy="" (seed,="" forage,="" hay),="" alfalfa="" (forage,="" hay),="" and="" clover="" (forage,="" hay)="" at="" 0.1="" part="" per="" million="" (ppm).="" these="" tolerances="" will="" expire="" and="" be="" automatically="" revoked="" without="" further="" action="" by="" epa="" on="" april="" 15,="" 1998.="" vii.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" issued="" by="" epa="" under="" new="" ffdca="" section="" 408(e)="" and="" (l)(6)="" as="" was="" provided="" in="" the="" old="" ffdca="" section="" 408="" and="" section="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" 60="" days,="" rather="" than="" 30="" days.="" epa="" currently="" has="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" hearing="" requests.="" these="" regulations="" will="" require="" some="" modification="" to="" reflect="" the="" new="" law.="" however,="" until="" those="" modifications="" can="" be="" made,="" epa="" will="" continue="" to="" use="" those="" procedural="" regulations="" with="" appropriate="" adjustments="" to="" reflect="" the="" new="" law.="" any="" person="" may,="" by="" april="" 21,="" 1997,="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" (including="" the="" automatic="" revocation="" provision)="" and="" may="" also="" request="" a="" hearing="" on="" those="" objections.="" objections="" and="" hearing="" requests="" must="" be="" filed="" with="" the="" hearing="" clerk,="" at="" the="" address="" given="" in="" ``addresses''="" at="" the="" beginning="" of="" this="" document="" (40="" cfr="" 178.20).="" a="" copy="" of="" the="" objections="" and/or="" hearing="" requests="" filed="" with="" the="" hearing="" clerk="" should="" be="" submitted="" to="" the="" opp="" docket="" for="" this="" rulemaking.="" the="" objections="" submitted="" must="" specify="" the="" provisions="" of="" the="" regulation="" deemed="" objectionable="" and="" the="" grounds="" for="" the="" objections="" (40="" cfr="" 178.25).="" each="" objection="" must="" be="" accompanied="" by="" the="" fee="" prescribed="" by="" 40="" cfr="" 180.33(i).="" if="" a="" hearing="" is="" requested,="" the="" objections="" must="" include="" a="" statement="" of="" the="" factual="" issues="" on="" which="" a="" hearing="" is="" requested,="" the="" requestor's="" contentions="" on="" such="" issues,="" and="" a="" summary="" of="" any="" evidence="" relied="" upon="" by="" the="" requestor="" (40="" cfr="" 178.27).="" a="" request="" for="" a="" hearing="" will="" be="" granted="" if="" the="" administrator="" determines="" that="" the="" material="" submitted="" shows="" the="" following:="" there="" is="" genuine="" and="" substantial="" issue="" of="" fact;="" there="" is="" a="" reasonable="" possibility="" that="" available="" evidence="" identified="" by="" the="" requestor="" would,="" if="" established,="" resolve="" one="" or="" more="" of="" such="" issues="" in="" favor="" of="" the="" requestor,="" taking="" into="" account="" uncontested="" claims="" or="" facts="" to="" the="" contrary;="" and="" resolution="" of="" the="" factual="" issues="" in="" the="" manner="" sought="" by="" the="" requestor="" would="" be="" adequate="" to="" justify="" the="" action="" requested="" (40="" cfr="" 178.32).="" information="" submitted="" in="" connection="" with="" an="" objection="" or="" hearing="" request="" may="" be="" claimed="" confidential="" by="" marking="" any="" part="" or="" all="" of="" that="" information="" as="" confidential="" business="" information="" (cbi).="" information="" so="" marked="" will="" not="" be="" disclosed="" except="" in="" accordance="" with="" procedures="" set="" forth="" in="" 40="" cfr="" part="" 2.="" a="" copy="" of="" the="" information="" that="" does="" not="" contain="" cbi="" must="" be="" submitted="" for="" inclusion="" in="" the="" public="" record.="" information="" not="" marked="" confidential="" may="" be="" disclosed="" publicly="" by="" epa="" without="" prior="" notice.="" viii.="" public="" record="" a="" record="" has="" been="" established="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300453].="" a="" public="" version="" of="" this="" record,="" which="" does="" not="" include="" any="" information="" claimed="" as="" cbi,="" is="" available="" for="" inspection="" from="" 8:30="" a.m.="" to="" 4="" p.m.,="" monday="" through="" friday,="" excluding="" legal="" holidays.="" the="" public="" record="" is="" located="" in="" room="" 1132="" of="" the="" public="" response="" and="" program="" resources="" branch,="" field="" operations="" division="" (7506c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" highway,="" arlington,="" va.="" the="" official="" record="" for="" this="" rulemaking,="" as="" well="" as="" the="" public="" version,="" as="" described="" above,="" is="" kept="" in="" paper="" form.="" accordingly,="" in="" the="" event="" there="" are="" objections="" and="" hearing="" requests,="" epa="" will="" transfer="" any="" copies="" of="" objections="" and="" hearing="" requests="" received="" electronically="" into="" printed,="" paper="" form="" as="" they="" are="" received="" and="" will="" place="" the="" paper="" copies="" in="" the="" official="" rulemaking="" record.="" the="" official="" rulemaking="" record="" is="" the="" paper="" record="" maintained="" at="" the="" address="" in="" ``addresses''="" at="" the="" beginning="" of="" this="" rule.="" ix.="" regulatory="" assessment="" requirements="" under="" executive="" order="" 12866="" (58="" fr="" 51735,="" october="" 4,="" 1993),="" this="" action="" is="" not="" a="" ``significant="" regulatory="" action''="" and,="" since="" this="" action="" does="" not="" impose="" any="" information="" collection="" requirements="" as="" defined="" by="" the="" paperwork="" reduction="" act,="" 44="" u.s.c.="" 3501="" et="" seq.,="" it="" is="" not="" subject="" to="" review="" by="" the="" office="" of="" management="" and="" budget.="" in="" addition,="" this="" action="" does="" not="" impose="" any="" enforceable="" duty="" or="" contain="" any="" unfunded="" mandate="" as="" described="" in="" the="" unfunded="" mandates="" reform="" act="" of="" 1995="" (pub.="" l.="" 104-4),="" or="" require="" prior="" consultation="" with="" state="" officials="" as="" specified="" by="" executive="" order="" 12875="" (58="" fr="" 58093,="" october="" 28,="" 1993),="" or="" special="" considerations="" as="" required="" by="" executive="" order="" 12898="" (59="" fr="" 7629,="" february="" 16,="" 1994).="" under="" 5="" u.s.c.="" 801(a)(1)(a)="" of="" the="" administrative="" procedure="" act="" (apa)="" as="" amended="" by="" the="" small="" business="" regulatory="" enforcement="" fairness="" act="" of="" 1996="" (title="" ii="" of="" pub.="" l.="" 104-121,="" 110="" stat.="" 847),="" epa="" submitted="" a="" report="" containing="" this="" rule="" and="" other="" required="" information="" to="" the="" u.s.="" senate,="" the="" u.s.="" house="" of="" representatives="" and="" the="" comptroller="" general="" of="" the="" general="" accounting="" office="" prior="" to="" publication="" of="" the="" rule="" in="" today's="" federal="" register.="" this="" rule="" is="" not="" a="" ``major="" rule''="" asdefined="" by="" 5="" u.s.c.="" 804(2)="" of="" the="" apa="" as="" amended.="" list="" of="" subjects="" in="" 40="" cfr="" part="" 180="" environmental="" protection,="" administrative="" practice="" and="" procedure,="" agricultural="" commodities,="" pesticides="" and="" pests,="" reporting="" and="" recordkeeping="" requirements.="" dated:="" february="" 6,="" 1997.="" peter="" caulkins,="" acting="" director,="" office="" of="" pesticide="" programs.="" [[page="" 7684]]="" therefore,="" 40="" cfr="" chapter="" i="" is="" amended="" as="" follows:="" part="" 180--[amended]="" 1.="" the="" authority="" citation="" for="" part="" 180="" continues="" to="" read="" as="" follows:="" authority:="" 21="" u.s.c.="" 346a="" and="" 371.="" 2.="" in="" sec.="" 180.284,="" paragraph="" (c)="" is="" amended="" by="" revising="" the="" introductory="" text="" and="" adding="" in="" alphabetical="" order="" new="" entries="" to="" the="" table="" to="" read="" as="" follows:="" sec.="" 180.284="" zinc="" phosphide,="" tolerances="" for="" residues.="" *="" *="" *="" *="" *="" (c)="" time-limited="" tolerances="" are="" established="" for="" residues="" of="" phosphine="" resulting="" from="" the="" use="" of="" the="" rodenticide="" zinc="" phosphide="" in="" connection="" with="" use="" of="" the="" pesticide="" under="" fifra="" section="" 18="" emergency="" exemptions="" granted="" by="" epa.="" the="" tolerances="" are="" specified="" in="" the="" following="" table.="" the="" tolerances="" expire="" on="" the="" date="" specified="" in="" the="" table.="" ------------------------------------------------------------------------="" expiration/="" commodity="" parts="" per="" million="" revocation="" date="" ------------------------------------------------------------------------="" alfalfa="" (forage)................="" 0.1="" april="" 15,="" 1998="" alfalfa="" (hay)...................="" 0.1="" april="" 15,="" 1998="" clover="" (forage).................="" 0.1="" april="" 15,="" 1998="" clover="" (hay)....................="" 0.1="" april="" 15,="" 1998="" *="" *="" *="" *="" *="" timothy="" (forage)................="" 0.1="" april="" 15,="" 1998="" timothy="" (hay)...................="" 0.1="" april="" 15,="" 1998="" timothy="" (seed)..................="" 0.1="" april="" 15,="" 1998="" ------------------------------------------------------------------------="" [fr="" doc.="" 97-3931="" filed="" 2-19-97;="" 8:45="" am]="" billing="" code="" 6560-50-f="">