[Federal Register Volume 62, Number 70 (Friday, April 11, 1997)]
[Rules and Regulations]
[Pages 17742-17748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9375]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 180, 185, and 186

[OPP-300470; FRL-5598-2]
RIN 2070-AC78


Norflurazon; Pesticide Tolerance 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 the herbicide norflurazon in or on the raw agricultural 
commodities bermudagrass hay and forage in connection with EPA's 
granting of emergency exemptions under section 18 of the Federal 
Insecticide, Fungicide, and Rodenticide Act authorizing use of 
norflurazon on bermudagrass in the states of Alabama, Georgia, 
Louisiana, Mississippi, and Texas. This regulation establishes maximum 
permissible levels for residues of norflurazon 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 by EPA on November 30, 1998.

DATES: This regulation becomes effective April 11, 1997. Objections and 
requests for hearings must be received by EPA on or before June 10, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300470], 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-300470], 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,

[[Page 17743]]

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: <a href="/cdn-cgi/l/email-protection#711e01015c151e121a1405311401101c10181d5f1401105f161e07"><span class="__cf_email__" data-cfemail="600f10104d040f030b0514200510010d01090c4e0510014e070f16">[email protected]</span></a>. 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-300470]. 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 22202, (703) 308-8326, e-mail: 
<a href="/cdn-cgi/l/email-protection#ddadb8b0bfb8afa9b2b3f3b1b4bfbfa49db8adbcb0bcb4b1f3b8adbcf3bab2ab"><span class="__cf_email__" data-cfemail="d4a4b1b9b6b1a6a0bbbafab8bdb6b6ad94b1a4b5b9b5bdb8fab1a4b5fab3bba2">[email protected]</span></a>.

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 tolerances for 
residues of norflurazon on bermudagrass forage at 2 ppm and 
bermudagrass hay at 3 ppm. These tolerances will expire on November 30, 
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 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) 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) 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. 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 Norflurazon on Bermudagrass and FFDCA 
Tolerances

    EPA has authorized use under FIFRA section 18 of norflurazon on 
bermudagrass hay meadows and patures for control of grassy weeds. 
Bermudagrass requires at least 2 years to completely cover a planted 
area and successfully compete with annual grassy weeds. Successful 
establishment during the first 2 years is critically important to 
profitable production from a bermudagrass hay meadow. Annual grassy 
weed encroachment and resulting variable bermudagrass stands will 
reduce the quantity of hay produced and the overall quality. A hay 
field does not reach maximum hay production for 3 or 4 years after 
establishment depending on the degree of success in establishment. For 
the next 6 to 7 years, growers should receive maximum economic yield 
and return on their annual investments. The market will not accept 
bermudagrass hay contaminated with weeds or annual grasses. 
Bermudagrass stands often begin to decline after about 10 years due to 
diseases, insect problems, fertility imbalances, or environmental 
stresses. Establishment of a new stand of bermudagrass is the most cost 
effective way of maintaining maximum quality and quantity of hay. 
Atrazine and simazine, which traditionally provided control of these 
weeds, were voluntarily canceled in 1990 resulting in this urgent, 
nonroutine situation. After having reviewed their submissions, EPA 
concurs that emergency conditions exist.
    As part of its assessment of these specific exemptions, EPA 
assessed the potential risks presented by residues of norflurazon on 
bermudagrass hay and forage. 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 norflurazon will permit the marketing of 
bermudagrass hay and forage treated in accordance with the provisions 
of the section 18 emergency exemptions.

[[Page 17744]]

Consistent with the need to move quickly on these emergency exemptions 
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 section 408(e) 
as provided in section 408(l)(6). Although these tolerances will expire 
and be revoked by EPA on November 30, 1998, under FFDCA section 
408(l)(5), residues of norflurazon not in excess of the amount 
specified in these tolerances remaining in or on bermudagrass hay and 
forage 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 norflurazon meets the 
requirements for registration under FIFRA section 3 for use on 
bermudagrass or whether permanent tolerances for norflurazon for 
bermudagrass hay and forage would be appropriate. This action by EPA 
does not serve as a basis for registration of norflurazon 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 Alabama, Georgia, 
Louisiana, Mississippi, and Texas to use this product on this crop 
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 norflurazon, 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 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 
these actions. Norflurazon is registered by EPA for several 
agricultural as well as non-agricultural uses. EPA believes it has 
sufficient data to assess the hazards of norflurazon and to make a 
determination on aggregate exposure, consistent with section 408(b)(2), 
for the time-limited tolerances for residues of norflurazon on 
bermudagrass hay and forage. 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 
norflurazon at 0.02 milligrams(mg)/kilogram(kg)/day. The RfD was 
established based on a NOEL (no observable effect level) of 1.53 mg/kg/
day in a 6-month dog feeding study. The LEL (lowest effect level) was 
based on absolute and relative liver weight and increased cholesterol 
levels. An uncertainty factor (UF) of 100 was used to account for both 
inter-species extrapolation and intra-species variability.
    2. Acute toxicity. Agency toxicologists have recommended that the 
developmental NOEL of 30 mg/kg/day from the rabbit developmental 
toxicity study be used for acute dietary risk calculations. The 
developmental LEL of 60 mg/kg/day is based on increased skeletal 
variations. The population of concern for this risk assessment is 
females 13+ years old.
    3. Short-term non-dietary inhalation and dermal toxicity. OPP 
recommends use of the 21-day dermal toxicity study

[[Page 17745]]

in rabbits for short- and intermediate-term MOE calculations.
    The NOEL was 375 mg/kg/day and the LEL of 1,000 mg/kg/day was based 
on increased absolute and relative liver weights, and increased 
alkaline phosphatase.
    4. Carcinogenicity. Norflurazon is classified as a ``Group C'', 
possible human carcinogen, by the Carcinogenicity Peer Review Committee 
(CPRC). The CPRC recommended using the RfD approach for quantification 
of human risk.

B. Aggregate Exposure

    Tolerances for residues of norflurazon in or on food/feed 
commodities are currently expressed in terms of the herbicide 
norflurazon (4-chloro-5-(methylamino)-2-(alpha, alpha, alpha-trifluoro-
m-tolyl)-3-(2H)-pyridazinone) and its desmethyl metabolite 4-chloro-5-
(amino)-2-alpha, alpha, alpha-trifluoro-m-tolyl)-3(2H)-pyridazinone (40 
CFR 180.356, 185.4450, and 186.4450). Existing norflurazon tolerances 
for meat, milk, poultry, and eggs are not expected to be exceeded and 
are adequate to cover any secondary residues which might occur in 
animal commodities as a result of this use on bermudagrass.
    For the purpose of assessing chronic dietary exposure from 
norflurazon, EPA assumed tolerance level residues and 100% of crop 
treated for the proposed use of norflurazon. These conservative 
assumptions result in overestimation of human dietary exposures.
    In examining aggregate exposure, FQPA directs EPA to consider 
available information concerning exposures from the pesticide residue 
in food and all other non-occupational exposures. The primary non-food 
sources of exposure the Agency looks at include drinking water (whether 
from groundwater or surface water), and exposure through pesticide use 
in gardens, lawns, or buildings (residential and other indoor uses).
    Because the Agency lacks sufficient water-related exposure data to 
complete a comprehensive drinking water risk assessment for many 
pesticides, EPA has commenced and nearly completed a process to 
identify a reasonable yet conservative bounding figure for the 
potential contribution of water-related exposure to the aggregate risk 
posed by a pesticide. In developing the bounding figure, EPA estimated 
residue levels in water for a number of specific pesticides using 
various data sources. The Agency then applied the estimated residue 
levels, in conjunction with appropriate toxicological endpoints (RfDs 
or acute dietary NOELs) and assumptions about body weight and 
consumption, to calculate, for each pesticide, the increment of 
aggregate risk contributed by consumption of contaminated water. While 
EPA has not yet pinpointed the appropriate bounding figure for 
consumption of contaminated water, the ranges the Agency is continuing 
to examine are all below the level that would cause norflurazon to 
exceed the RfD if the tolerances being considered in this document were 
granted. The Agency has therefore concluded that the potential 
exposures associated with norflurazon in water, even at the higher 
levels the Agency is considering as a conservative upper bound, would 
not prevent the Agency from determining that there is a reasonable 
certainty of no harm if the tolerances are granted.
    Based on the available studies used in EPA's assessment of 
environmental risk, norflurazon is persistent and mobile. The 
``Pesticides in Groundwater Data Base'' (EPA 734-12-92-001, September 
1992) reported sampling of wells for norflurazon residues in Texas and 
California. Texas reported 188 wells sampled, California reported 6 
wells sampled. No detection of residues were reported in any of the 
sampled wells. There is no established Maximum Concentration Level 
(MCL) for residues of norflurazon in drinking water. No drinking water 
health advisory levels have been established for norflurazon.
    Norflurazon is registered for uses, such as fencerows and around 
buildings, that could result in non-occupational exposure, and EPA 
acknowledges that there may be short-, intermediate-, and long-term 
non-occupational, non-dietary exposure scenarios. At this time, the 
Agency has insufficient information to assess the potential risks from 
such exposure.
    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.'' The Agency believes that ``available 
information'' in this context might include not only toxicity, 
chemistry, and exposure data, but also scientific policies and 
methodologies for understanding common mechanisms of toxicity and 
conducting cumulative risk assessments. For most pesticides, although 
the Agency has some information in its files that may turn out to be 
helpful in eventually determining whether a pesticide shares a common 
mechanism of toxicity with any other substances, EPA does not at this 
time have the methodologies to resolve the complex scientific issues 
concerning common mechanism of toxicity in a meaningful way. EPA has 
begun a pilot process to study this issue further through the 
examination of particular classes of pesticides. The Agency hopes that 
the results of this pilot process will increase the Agency's scientific 
understanding of this question such that EPA will be able to develop 
and apply scientific principles for better determining which chemicals 
have a common mechanism of toxicity and evaluating the cumulative 
effects of such chemicals. The Agency anticipates, however, that even 
as its understanding of the science of common mechanisms increases, 
decisions on specific classes of chemicals will be heavily dependent on 
chemical-specific data, much of which may not be presently available.
    Although at present the Agency does not know how to apply the 
information in its files concerning common mechanism issues to most 
risk assessments, there are pesticides as to which the common mechanism 
issues can be resolved. These pesticides include pesticides that are 
toxicologically dissimilar to existing chemical substances (in which 
case the Agency can conclude that it is unlikely that a pesticide 
shares a common mechanism of activity with other substances) and 
pesticides that produce a common toxic metabolite (in which case common 
mechanism of activity will be assumed).
    EPA does not have, at this time, available data to determine 
whether norflurazon has a common mechanism of toxicity with other 
substances or how to include this pesticide in a cumulative risk 
assessment. Unlike other pesticides for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, 
norflurazon does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that norflurazon has a common mechanism of toxicity 
with other subtances.

C. Safety Determinations for U.S. Population

    Taking into account the completeness and reliability of the 
toxicity data, EPA has concluded that chronic dietary exposure to 
norflurazon in food from published tolerances will utilize 10 percent 
of the RfD for the U.S. population. EPA generally has no concern for 
chronic exposures below 100 percent of the RfD because the RfD 
represents the level at or below which daily aggregate dietary exposure 
over a lifetime will not pose appreciable risks to human health. The 
acute dietary

[[Page 17746]]

exposure endpoint of concern for norflurazon is developmental. For the 
population of concern, females 13+ years, a MOE of 3,000 was 
calculated. This MOE value does not exceed the Agency's level of 
concern for acute dietary exposure. Dietary cancer concerns are 
adequately addressed by the chronic exposure analysis using the RfD. 
Short- and intermediate-term aggrgate risk takes into account exposure 
from chronic dietary food and water plus indoor and outdoor residential 
exposure. Short- and intermediate-term MOE's for the U.S. population 
was calculated to be 11,000. Despite the potential for exposure to 
norflurazon from drinking water and outdoor residential uses, EPA does 
not expect the aggregate exposure to exceed 100% of the RfD or the 
Agency's level of concern for acute, short- and intermediate-term 
dietary exposure. EPA concludes that there is a reasonable certainty 
that no harm will result for the U.S. poulation from aggregate exposure 
to norflurazon residues.

D. Determination of Safety for Infants and Children

    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of exposure (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 exposure (safety) will be safe for infants and 
children. Margins of exposure (safety) are often referred to as 
uncertainty (safety) factors. EPA believes that reliable data support 
using the standard margin of exposure (usually 100x for combined inter- 
and intra-species variability)) and not the additional ten-fold margin 
of exposure 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 margin of exposure. Based on 
current toxicological data requirements, the data base for norflurazon 
relative to pre- and post-natal toxicity is complete.
    The results of the rabbit developmental toxicity study required an 
acute dietary risk assessment be performed for additional pre-natal 
sensitivity due to skeletal variations. However, the MOE of 3,000 is 
adequate to protect against any pre-natal fetal risks. In the rabbit 
developmental toxicity study, the NOEL of 30 mg/kg/day was the same for 
both developmental and maternal toxicity. The developmental LEL of 60 
mg/kg/day was based on increased skeletal variations and decreased mean 
fetal weight. The maternal LEL of 60 mg/kg/day was based on decreased 
body weight and abortions. Although there were developmental effects at 
60 mg/kg/day in rabbit fetuses, these findings only occurred in the 
presence of maternal toxicity. In the rat developmental toxicity study, 
the developmental NOEL was identified at; 400 mg/kg/day (HDT), while 
the maternal (systemic) NOEL was <100 mg/kg/day. The acute dietary 
exposure endpoint of concern for norflurazon is developmental 
(increased skeletal variations). For the population subgroup of 
concern, females 13+ years, the calculated Margin of Exposure (MOE) 
value is 3,000.
    The results of the 2-generation reproductive toxicity study will be 
used to assess the potential for additional pre- and post-natal 
sensitivity. The parental (systemic) NOEL was 10.2 mg/kg/day and the 
reproductive NOEL was 50.8 mg/kg/day. The reproductive LEL of 102.5 mg/
kg/day was based on increased pup deaths, increased stillborns and 
decreased lactation index. These effects occurred in the presence of 
maternal toxicity. This indicates that there is no extra post-natal 
sensitivity. The NOEL used to establish the RfD is approximately 10-
fold lower than the pup NOEL from the reproduction study; therefore, 
EPA concludes that reliable data support use of the standard 
uncertainty factor as protecting the safety of infants and children and 
that an additional 10-fold margin of exposure is unnecessary.
    EPA has concluded that the percent of the RfD that will be utilized 
by chronic dietary (food) exposure to residues of norflurazon ranges 
from 15% for nursing infants (<1 year old) up to 47% for non-nursing 
infants (<1 year 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. The addition of 
potential exposure from norflurazon residues in drinking water is not 
expected to result in an exposure which would exceed the RfD. 
Therefore, EPA concludes that there is a reasonable certainty that no 
harm will result to infants and children from aggregate exposure to 
norflurazon residues.

V. Other Considerations

    The metabolism of norflurazon in plants and animals is adequately 
understood for the purposes of this tolerance. There are no Codex 
maximum residue levels established for residues of norflurazon and its 
desmethyl metabolite in or on bremudagrass hay and forage. The residue 
of concern, for the purposes of this tolerance, is norflurazon and its 
desmethyl metabolite. Adequate methods for purposes of data collection 
and enforcement of tolerances for norflurazon and its desmethyl 
metabolite are available. Methods for determining norflurazon residues 
are described in the Pesticide Analytical Manual, Vol. II.

VI. Conclusion

    Therefore, tolerances in connection with the FIFRA section 18 
emergency exemptions are established for residues of norflurazon in or 
on bermudagrass forage at 2 ppm and bermudagrass hay at 3 ppm. These 
tolerances will expire and be revoked by EPA on November 30, 1998. In 
addition to the new tolerance being established, since FQPA eliminates 
all distinctions between raw and processed food, EPA is combining the 
tolerances that now appear in Secs. 185.4450 and 186.4450 into 
Sec. 180.356. Subsequently, Secs. 185.4450 and 186.4450 are removed.

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 June 10, 1997 file written objections to any 
aspect of this regulation (including the 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

[[Page 17747]]

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

    A record has been established for this rulemaking under docket 
number [OPP-300470]. 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 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.
    This action does not impose any enforceable duty, or contain any 
``unfunded mandates'' as described in Title II of the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as 
specified by Executive Order 12875 (58 FR 58093, October 28, 1993), 
entitled Enhancing the Intergovernmental Partnership, or special 
consideration 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. Nonetheless, the Agency has previously 
assessed whether establishing tolerances or exemptions from tolerance, 
raising tolerance levels, or expanding exemptions adversely impact 
small entities and concluded, as a generic matter, that there is no 
adverse impact. (46 FR 24950) (May 4, 1981).
    Under 5 U.S.C. 801(a)(1)(A) of 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'' as defined by 5 U.S.C. 804(2) of the 
APA as amended.

List of Subjects in 40 CFR Parts 180, 185, and 186

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Feed additive, Food additive, Pesticides and 
pests, Reporting and recordkeeping requirements.

    Dated: April 4, 1997.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR Chapter I is amended as follows:

PART 180--[AMENDED]

    1. In part 180:
    a. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 346a and 371.

    b. Section 180.356 is amended by redesignating the existing text as 
paragraph (a), adding a paragraph heading and adding alphabetically 
three new entries to the table therein to the newly redesignated 
paragraph (a), adding a new paragraph (b), and reserving paragraphs (c) 
and (d) to read as follows:


Sec. 180.356   Norflurazon, tolerances for residues.

    (a) General. * * *

                                                                        
------------------------------------------------------------------------
                 Commodity                        Parts per million     
------------------------------------------------------------------------
                                                                        
                  *        *        *        *        *                 
Citrus molasses...........................  1.0                         
                                                                        
                  *        *        *        *        *                 
Dried citrus pulp.........................  0.4                         
                                                                        
                  *        *        *        *        *                 
Dried hops................................  3.0                         
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the herbicide norflurazon (4-chloro-5-
(methylamino)-2-(alpha, alpha, alpha-trifluoro-m-tolyl)-3-
(2H)pyridazinone) and its desmethyl metabolite 4-chloro-5-(amino)-2-
alpha, alpha, alpha-trifluoro-m-tolyl)-3(2H)-pyridazinone 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 will be revoked on the date specified in the 
table by EPA.

                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    Revocation Date 
------------------------------------------------------------------------
Grasses, Bermuda, Forage          2.0                 November 30, 1998 
Grasses, Bermuda, Hay             3.0                 November 30, 1998 
------------------------------------------------------------------------

    (c) Tolerances with regional registration. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

PART 185--[AMENDED]

    2. In part 185:
    a. The authority citation for part 185 continues to read as 
follows:

    Authority: 21 U.S.C. 346a and 348.

Sec. 185.4450 [Removed]

    b. Section 185.4450 is removed.

[[Page 17748]]

PART 186--[AMENDED]

    3. In part 186:
    a. The authority citation for part 186 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 348 and 701.

Sec. 186.4450 [Removed]

    b. Section 186.4450 is removed.

[FR Doc. 97-9375 Filed 4-10-97; 8:45 am]
BILLING CODE 6560-50-F


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