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norflurazon (Zorial, Solicam) Pesticide Tolerance 7/96

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 9F3766/R2254; FRL-5385-3]
RIN 2070-AB78
 
Norflurazon; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final Rule.
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SUMMARY: This rule establishes tolerances 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)-pyradazinone) in 
or on the following raw agricultural commodities (RACs): alfalfa, 
forage, alfalfa, hay, alfalfa, seed; and in or on meat by products 
(except liver) of cattle, goats, hogs, horses, and sheep and in or on 
liver of cattle, goats, hogs, horses and sheep resulting from the use 
of norflurazon in the culture of alfalfa. This regulation to establish 
a maximum permissible level for the residues of norflurazon was 
requested in a petition submitted by Sandoz Agro, Inc. of 1300 East 
Touhy Avenue Des Plaines, Illinois 60018-3300.
EFFECTIVE DATE: July 29, 1996.
ADDRESSES: Written objections and hearing requests, identified by the 
docket number, [PP 9F3766/R2254], may be submitted to: Hearing clerk 
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., 
Washington, DC 20460. A copy of any objections and hearing requests 
filed with the Hearing Clerk should be identified by the docket number 
and 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 copy of objections and hearing requests to Rm. 1132, 
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees 
accompanying objections shall be labeled ``Tolerance Petition Fees'' 
and forwarded to: EPA Headquarters Accounting Operations Branch, OPP 
(Tolerance Fees), P.O. Box 36277M, Pittsburgh, PA 15251. Information 
not marked confidential may be disclosed publicly by EPA without prior 
notice. An electronic copy of objections and hearing requests filed 
with the Hearing Clerk may be submitted to OPP by sending electonic 
mail (e-mail) to: opp-docket@epamail.epa.gov.
    Copies of electronic objections and hearing requests must be 
submitted as an ASCII file avoiding the use of special characters and 
any form of encryption. Copies of electronic objections and hearing 
requests will also be accepted on disks in Wordperfect 5.1 file format 
or as ASCII file format. All copies of electronic objections and 
hearing requests must be identified by the docket number [PP 9F3766/
R2254]. No Confidential Business Information (CBI) should be submitted 
through e-mail. Copies of electronic objections and hearing requests on 
this rule may be filed online at many Federal Depository Libraries. 
Additional information on electronic submissions can be found in the 
SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: By mail: Joanne Miller, Product 
Manager (23) Registration Division (7505C), Office of Pesticide 
Programs. Environment Protection Agency, 401 M St. SW., Washington, DC 
20460. Office location and telephone number: Rm. 237, CM #2, 1921 
Jefferson Davis Highway, Arlington, VA 22202. (703) 305-6224, e-mail: 
miller.joanne@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA issued a notice of filing, published in 
the Federal Register of June 29, l989 (54 FR 27423), which announced 
that Sandoz Crop Protection Corp., of 1300 East Touhy Avenue, Des Plaines, 
IL 60018 had submitted a request for an EPA Pesticide Petition, PP 
9F3766, for the purpose of amending 40 CFR part 180, pursuant to 
section 408(d) of the Federal Food, Drug and Cosmetic Act (FFDCA), 21 
U.S.C. 346a(d), by establishing tolerances for combined 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 or on alfalfa, forage at 3.0 ppm, alfalfa, hay 
at 5.0 ppm, alfalfa, seed at 0.1 ppm. The proposed analytical method of 
determining residues was gas chromatography.
    A second notice of filing was published in the Federal Register (61 
FR 30238, June 14, l996) (FRL-5370-7). The notice announced that Sandoz 
had revised requested tolerances for residues of 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 or on the 
following raw agricultural commodities: alfalfa, forage at 3.0 ppm, 
alfalfa, hay at 5.0 ppm and alfalfa, seed at 0.1 ppm; and in or on 
meat-by-products (except liver) of cattle, goats, hogs, horses, and 
sheep at 0.1 ppm and in or on liver of cattle, goats, hogs, horses and 
sheep at 0.25 ppm.
    There were no comments received in response to the notices of 
filing. The scientific data submitted in the petition and other 
relevant material have been evaluated. The toxicological data 
considered in support of the proposed tolerances include:
    1. The following acute studies with norflurazon:
    Acute Oral, Rat (Male) LD<INF>50: 9.3 g/kg, Toxicity Category 
IV.
    Acute Dermal, Rabbit: LC<INF>50 <ls-thn-eq>20,000 mg/kg, 
Toxicity Category IV.
    Acute Inhalation, Acceptable study unavailable.
    Primary Eye Irritation, Rabbit: Toxicity Category IV.
    Primary Dermal Irritation, Rabbit, non-irritating: Category IV.
    Dermal Sensitization, Guinea Pig, technical norflurazon at 0.1 
percent did not cause sensitization in males, a repeat study is 
required because of flaws in the study.
    2. A 90-day rat feeding study at nominal dosages of 0, 12.5, 25.0 
and 125.0 mg/kg/day. There were no significant effects of norflurazon 
on survival, body weight, body weight gain and food consumption in male 
and female rats at any dose level. At the 125.0 mg/kg/day dose level, 
the following effects were observed at 13 weeks: an increase in red 
cell count of 19 percent in male rats; a decrease in alkaline 
phosphatase activity of 38 percent and 42 percent in male and female 
rats, respectively; a decrease in SGOT activity of 36 percent in female 
rats; an increase in liver weight of 14 percent and 12 percent in male 
and female rats, respectively; an increase in thyroid weight of 96 
percent in male rats; and an increase in the incidence of hypertrophic 
acinar epithelium and colloid depletion of the thyroid in male rats. At 
the 25.0 mg/kg/day level after 13 weeks of treatment, thyroid weight 
was increased by 20 percent in male rats with an increased incidence of 
hypertrophic acinar epithelium and colloid depletion. In addition, red 
cell count was increased by 14 percent in male rats, SGOT was decreased 
by 10 percent in female rats, and liver weight was increased by 14 
percent in males. The systemic no-observable-effect-level (NOEL) was 
considered to be 12.50 mg/kg/day in male rats, and 25.0 mg/kg/day in 
female rats. The systemic lowest-effect-level (LEL) was considered to 
be 25.0 mg/kg/day in male rats based on increased red cell count, 
increased thyroid and liver weight, and increased incidence of 
hypertropic acinar epithelium and colloid deposition in the thyroid. 
The systemic LEL was considered to be 125.0 mg/kg/day in female rats, 
based on an increased liver weight and liver-to-body weight ratio. The 
decreased alkaline phosphatase and SGOT activity observed in females at 
this dose were of unknown biological significance.
    3. A 6-month dog feeding study at dosages of 0, 1.53, 5.02 and 
14.27 mg/kg/day for males and 0, 1.58, 4.77 and 17.75 mg/kg/day for 
females, technical norflurazon (99.2 percent a.i.). At the mid-dose 
level, liver weight was increased by 38 percent in male dogs and by 23 
percent in female dogs. Thyroid weight was increased by 33 percent in 
male dogs and 37 percent in female dogs at those dose levels. Also, as 
noted at the mid-dose level there were increases of cholesterol in both 
sexes (23 to 40 percent in males, 6 to 34 percent in females), a 
decrease in SGPT (36 to 38 percent in males, 13 to 20 percent in 
females) and SGOT (4 to 23 percent in males, 13 to 23 percent in 
females). At the highest level, similar changes were observed in male 
and female dogs, with the additional observation of a decrease in red 
cell count in female dogs (79 to 92 percent of control). The systemic 
NOEL was determined to be 1.53 mg/kg/day for males and 1.58 mg/kg/day 
for females. The systemic LEL was determined to be 5.02 mg/kg/day for 
males and 4.77 mg/kg/day for females, based on increased absolute and 
relative liver weight and increased cholesterol in both sexes.
    4. A 3-week rabbit dermal study with 80 percent norflurazon 
wettable powder. Dermal applications were made at doses of 150 mg 
(approximately 375 mg/kg/day) and 400 mg (approximately 1,000 mg/kg/
day) 5 days per week, 6 to 8 hours per day, for the 3-week study. The 
systemic NOEL was 375 mg/kg/day for males and females, and the systemic 
LEL was 1,000 mg/kg/day for males and females, based on increases in 
alkaline phosphatase activity, liver weight and liver to body weight 
ratio in both sexes. The dermal NOEL was also 375 mg/kg/day for both 
sexes, and the dermal LEL was 1,000 mg/kg/day for both sexes, based on 
slight erythema observed immediately after bandage removal.
    5. A 28-day rat feeding study at dosages of 0, 25.0, 50.0 and 250.0 
mg/kg/day with a NOEL of 50.0 mg/kg/day. The effect was hyperplasia and 
hypertrophy of liver and higher liver, kidney, adrenal, and heart/body 
weight ratios.
    6. A 28-day mouse feeding study at dosages of 0, 10.5, 31.5, 63.0, 
and 378.0 mg/kg/day with a NOEL of 63.0 and 378.0 mg/kg/day with a NOEL 
of 63.0 mg/kg/day and a LEL of 378.0 mg/kg/day. The effect was diffused 
and smooth granular livers and an increase in the liver/body weight 
ratios.
    7. A rat dermal absorption study at dosages of 0, 0.1, 1.0 and 10.0 
mg/rat showing that no more than 0.1 percent of applied dose was 
absorbed at doses up to 10 mg/rat.
    8. Gene mutation assays in Salmonella typhimurium (strains TA98, 
TA100, TA1535, TA1537 and TA1538), and Saccharomyces cerevisiae (strain 
D4), in vitro, in the absence and presence of metabolic activation 
(Aroclor 1254 induced rat liver S-9). Norflurazon technical at 
concentrations of 0, 0.1, 1.0, 10, 100, or 500 <greek-m>g/plate (non-
activation) and concentrations of 0, 0.1, 1.0, 10.0, 100 or 500 
<greek-m>g/plate activation) [1,000 <greek-m>g/plate for TA1537 in a 
second assay] showed no evidence of mutagenicity in this study. There 
was no evidence of cytotoxicity in any of the strains at any of the 
dose concentrations used. Positive controls appeared adequate for all 
strains except TA100, where positive controls in the absence and 
presence of S-9 gave less than 2 times the number of revertants 
observed in negative controls. In the absence of data demontrating 
toxic effects, the highest concentration used in this study is 
inadequate and higher concentrations should have been assayed. In an in
vitro chromosomal aberration assay,norflurazon did not cause a
 clastogenic response at doses of 63 to 500 
<greek-m>g/ml in the absence of liver S-9 and at doses of 125 to 1,000 
<greek-m>g/ml in the presence of S-9. In an in vitro unscheduled DNA 
synthesis assay, norflurazon at doses ranging from 1 to 333 <greek-m>g/
ml failed to induce unscheduled DNA synthesis in primary rat 
hepatocytes.
    9. A developmental study in rats at dosages of 0, 100, 200 and 400 
mg/kg/day showed no maternal or developmental effects at 400 mg/kg/day. 
Maternal NOEL was <100 mg/kg/day; maternal LEL was 100 mg/kg/day, based 
on reductions in body weight for the period of dosing and for the 
dosing plus post-dosing period.
    10. A developmental study in rabbits at dosages of 0, 10, 30 and 60 
mg/kg/day showed maternal body weight decreases at 60 mg/kg/day. 
Developmental effects seen at 60 mg/kg/day were decreased fetal weight 
and incomplete ossification of the skull, fore and hind limb middle 
phalanx, metacarpal, and proximal epiphysis of the tibia. The NOEL for 
maternal toxicity was 30 mg/kg/day. The NOEL for developmental toxicity 
was 30 mg/kg/day.
    11. A three generation reproduction study in rats at dosages of 0, 
6.25, 18.75 and 51.25 mg/kg/day showed no apparent effects on 
reproductive performance at any dose level tested.
    12. A chronic toxicity and carcinogenicity study in Sprague-Dawley 
rats at dosages of 0, 6.25, 18.75 and 51.25 mg/kg/day for 104 weeks. No 
significant effects of technical norflurazon were evident for survival, 
body weight, body weight gain, or food consumption in male or female 
rats at any dose level tested. At the 18.75 mg/kg/day dose, liver 
weight was increased by 17 percent and 13 percent in males and females 
at 52 weeks and at 51.25 mg/kg/day by 24 percent and 27 percent in both 
sexes. At 104 weeks, liver weight was increased by 12 to 14 percent in 
both males and females, and kidney weight by 16 to 39 percent vs. 
controls. The weight of the thyroid was also increased at the 51.25 mg/
kg/day dose in male rats at 104 weeks. An increased incidence of 
hydronephrosis was observed in high dose male rats at 52 weeks vs. 
control, while the incidence of nephritis was increased in male rats 
(terminal sacrifice plus dying on test) at the 51.25 mg/kg/day dose. 
The incidence of tubular casts was increased in female rats at the high 
dose in those rats surviving to study termination. Other microscopic 
alterations observed at the high dose included an increased incidence 
of parathyroid hyperplasia (both sexes), hemosiderin pigment deposition 
in the spleen (males only) and liver (both sexes), and endometritis and 
squamous metaplasia of the uterus (females).
    The systemic NOEL was determined to be 18.75 mg/kg/day for both 
sexes. The systemic LEL was determined to be 51.25 mg/kg/day in both 
sexes, based on the increased kidney weight and accompanying 
microscopic pathologic changes, as well as the increase in liver weight 
in male and female rats and the increase in thyroid weight in males. 
There was no evidence of carcinogenicity for norflurazon.
    13. A carcinogenicity study in CD-1 HaM/ICR Swiss mice at dosages 
of 0, 12.8, 58.7 and 218.8 mg/kg/day technical norflurazon in the diet 
for 100 to 104 weeks. No significant effects were observed on body 
weight, body weight gain, clinical toxicity, and food consumption at 
any dose. Liver weight was increased by 9 percent and 15 percent in 
male and female mice at the 58.7 mg/kg/day dose, and by 27 percent and 
21 percent at the 218.8 mg/kg/day dose, respectively. The liver to body 
weight ratio was increased by 19 percent and 4 percent in male and 
female mice at the 58.7 mg/kg/day dose, and by 43 percent and 19 
percent at the 218.8 mg/kg/day dose, respectively. Increased incidence 
of enlarged spleen, nephritis, swollen/enlarged liver, and nodular 
enlargement of the liver were observed in high dose male mice, while 
increased incidences of pyelonephritis, enlarged liver, and cystic 
ovaries were observed in high dose female mice. Carcinogenic potential 
was evidenced by an increased incidence of hepatic adenoma and combined 
adenoma/carcinoma in high dose male mice.
    The systemic NOEL was determined to be 12.8 mg/kg/day for male 
mice, and 58.7 mg/kg/day for female mice. The systemic LEL was 
determined to be 58.8 mg/kg/day for male mice, based on the increased 
incidence of enlarged spleen, increased absolute and relative liver 
weight, and increased incidence of nephritis. The systemic LEL was 
determined to be 218.8 mg/kg/day for female mice, based on the 
increased incidence of enlarged liver and cystic ovaries, the increased 
absolute and relative liver weight, and the increased incidence of 
pyelonephritis.
    14. A rat metabolism study at single oral doses of 2 or 110 mg/kg, 
a single i.v. dose of 2.0 mg/kg, or a single oral dose at 2 mg/kg after 
animals had ingested 0.1 mg/kg for 14 days showed that less than 1.0 
percent of the administrated dose remained 96 hours after dosing. 
Thirteen metabolites were isolated. Norflurazon appears to be 
metabolized by N-demethylation, displacement of the chlorine atom by 
glutathione, glutatione attack on the aromatic ring, and replacement of 
the chlorine atom with hydrogen. Norflurazon appears to be rapidly 
absorbed from the gastrointestinal tract and extensively metabolized.
    The Agency's Health Effects Division Peer Review Committee 
classified norflurazon as a Group C, possible human carcinogen, based 
on the criteria in the Agency's Guideline for the Classification of 
Carcinogens (51 FR 33992-34003, September 24, l986) and the 
statistically significant increase in comparison to controls in 
hepatocellular adenomas and combined hepatocellular adenomas and 
carcinomas in male CD-1 mice as well as the statistically significant 
positive trend for hepatocellular adenomas and combined adenomas and 
carcinomas.
    That committee also recommended that for the purposes of risk 
characterization the Reference Dose (RfD) approach should be used for 
the quantification of human risk. This recommendation was supported by 
the presence of only benign tumors in only one sex of one species at 
one dose level, and adequate but negative mutagenicity data and no 
positive analogues. EPA believes norflurazon poses a negligible cancer 
risk to humans.
    Since the committee's review, the Agency has reevaluated the gene 
mutation assay in Salmonella typhimurium, strain TA100 and determined 
that it was inadequate. Sandoz Agro, Inc. has agreed to submit a repeat 
study by August 15, l996. The Agency does not believe that the study 
would significantly change the risk analysis for the use of norflurazon 
in the culture of alfalfa, as proposed in the subject petition.
    Using a 100-fold safety factor and the NOEL of 1.53 mg/kg/day 
determined by the most sensitive species (the 6-month dog feeding 
study), the RfD is 0.02 mg/kg/bwt/day. The theoretical maximum residue 
contribution (TMRC) from the established and the proposed tolerances is 
0.002041 and utilizes 10.2 percent of the RfD for the overall U.S 
population. The exposure of the most highly exposed subgroup in the 
population, non-nursing infants, is 0.009356 mg/kg/bwt/day and utilizes 
46.8 percent of the RfD.
    In a worst case estimate of dietary exposure with all residues at 
tolerance level and 100 percent of the commodities assumed to be 
treated with norflurazon is minimal for alfalfa commodities and does 
not exceed the RfD for any of the subgroups.
    Because developmental effects were seen in the rabbit developmental 
study, the Agency assessed acute dietary risk from developmental 
effects for the subgroup females (13+ years) the only appropriate group 
of acute dietary concern. The Margin of Exposure (MOE), a measure of 
how closely the high-end exposure comes to the NOEL, was calculated as 
the ratio of the NOEL to the exposure and determined to be 3,000. The 
Agency is not generally concerned unless the MOE is below 100 when 
based upon data generated in animal studies.
    Previous tolerances have been established for norflurazon in 
almonds, hulls and nutmeat; apples; apricots; asparagus; avocados; 
blackberries; blueberries; cattle, fat, meat, and meat-by-products 
(mbp); cherries; citrus fruit; cottonseed; cranberries; filberts; 
goats, fat, meat and mbp; grapes; hogs, fat, meat, and mbp; hops, 
green; horses, fat, meat, and mbp; milk; nectarines; peaches; peanuts; 
peanut hay, hulls and vines; pecans; pears; plums (fresh prunes); 
poultry, fat, meat and mbp; raspberries; sheep, fat, meat and mbp; 
soybeans, forage and hay; and walnuts. The metabolism of norflurazon in 
plants is adequately understood. Metabolism of norflurazon in livestock 
has been studied and tolerances for livestock commodities have been 
established. A ruminant study adequately identified the metabolites in 
milk, liver and kidney. Norflurazon was not detected in ruminant milk 
or tissue, and total radioactive residues in fat and muscle were <0.01 
part per million (ppm).
    The nature of the residue is adequately understood, and an adequate 
analytical method, gas chromatography using electron capture detection, 
is available for enforcement purposes. Because of the long lead time 
from establishing these tolerances to publication of the enforcement 
methodology in the Pesticide Analytical Manual, Vol. II, the analytical 
methodology is being made available in the interim to anyone interested 
in pesticide enforcement when requested from: Calvin Furlow, Public 
Information Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location and telephone number: Rm. 242, CM 
#2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703) 305-4432.
    The pesticide is considered useful for the purposes for which the 
tolerances are sought. Based on the information and data considered, 
the Agency concludes that the establishment of the tolerances will 
protect the public health. Registration for use in the culture of 
alfalfa will be conditioned on the basis that Sandoz Agro, Inc., the 
registrant will submit an acute inhalation study, a mutagenicity study 
and a dermal sensitization study. These studies are replacement studies 
for studies that were determined to be inadequate during the Agency's 
review of norflurazon for a Reregistration Eligibility Decision 
(presently not issued). There are presently no actions pending against 
the continued registration of this chemical. Therefore, the tolerances 
are established as set forth below.
    Any person adversely affected by this regulation may, within 30 
days after publication of this document in the Federal Register, file 
written objections to the regulation and may also request a hearing on 
those objections. Objections and hearing requests must be filed with 
the Hearing Clerk, at the address given above (40 CFR 178.20). A copy 
of the objections and/or hearing requests filed with the Hearing Clerk 
should be submitted to the OPP docket for this rulemaking. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issue(s) on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the objector (40 CFR 178.27). 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 issue(s) in the manner sought by the requestor would be 
adequate to justify the action requested (40 CFR 178.32).
     A record has been established for this rulemaking under docket 
number [PP 9F3766/R2254] (including comments and data submitted 
electronically as described below). 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 a.m. to 4:30 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 can 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 all comments received electronically into printed, 
paper form as they are received and will place the paper copies in the 
official rulemaking record which will also include all comments 
submitted directly in writing. The official rulemaking record is the 
paper record maintained at the Virginia address in ``ADDRESSES'' at the 
beginning of this document.
    Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency 
must determine whether the regulatory action is ``significant'' and 
therefore subject to all the requirements of the Executive Order (i.e., 
Regulatory Impact Analysis, review by the Office of Management and 
Budget (OMB)). Under section 3(f), the order defines ``significant'' as 
those actions likely to lead to a rule (1) having an annual effect on 
the economy of $100 million or more, or adversely and materially 
affecting a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local or tribal 
governments or communities (also known as ``economically 
significant''); (2) creating serious inconsistency or otherwise 
interfering with an action taken or planned by another agency; (3) 
materially altering the budgetary impacts of entitlement, grants, user 
fees, or loan programs; or (4) raising novel legal or policy issues 
arising out of legal mandates, the President's priorities, or the 
principles set forth in this Executive Order.
    Pursuant to the terms of this Executive Order, EPA has determined 
that this rule is not ``significant'' and is therefore not subject to 
OMB review.
    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, l993), 
entitled Enhancing the Intergovernmental Partnership, or special 
consideration as required by Executive Order 12898 (59 FR 7629, February
16, l994).
    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'' as 
defined by 5 U.S.C. 804(2) of the APA as amended.
    Pursuant to the requirements of the Regulatory Flexibility Act (5 
U.S.C. 601-612), the Administrator has determined that regulations 
establishing new tolerances or raising tolerance levels or establishing 
exemptions from tolerance requirements do not have a significant 
economic impact on a substantial number of small entities. A 
certification statement explaining the factual basis for this 
determination was published in the Federal Register of May 4, 1981 (46 
FR 24950).
List of Subjects in 40 CFR Part 180
     Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.
    Dated: July 18, 1996.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
    Therefore, 40 CFR Part 180 be 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. 180.356, the table is amended by adding alphabetically 
the entries for Alfalfa, forage; Alfalfa, hay; Alfalfa, seed; Cattle, 
liver; Goats, liver; Hogs, liver; Horse liver; and Sheep, liver, and by 
revising the entries for Cattle, mbyp; Goats, mbyp; Hogs, mbyp; Horse, 
mbyp; and Sheep, mbyp; to read as set forth below:
Sec. 180.356  Norflurazon; tolerances for residues.
*       *       *       *        *
------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
                                                                        
                  *        *        *        *        *                 
Alfalfa, forage............................................          3.0
Alfalfa, hay...............................................          5.0
Alfalfa, seed..............................................          0.1
                                                                        
                  *        *        *        *        *                 
Cattle, liver..............................................         0.25
Cattle, mbyp (except liver)................................          0.1
                                                                        
                  *        *        *        *        *                 
Goats, liver...............................................         0.25
Goats, mbyp (except liver).................................          0.1
                                                                        
                  *        *        *        *        *                 
Hogs, liver................................................         0.25
Hogs, mbyp (except liver)..................................          0.1
                                                                        
                  *        *        *        *        *                 
Horses, liver..............................................         0.25
Horses, mbyp (except liver)................................          0.1
                                                                        
                  *        *        *        *        *                 
Sheep, liver...............................................         0.25
Sheep, mbyp (except liver).................................          0.1
                                                                        
                  *        *        *        *        *                 
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[FR Doc. 96-19082 Filed 7-26-96; 8:45 am]
BILLING CODE 6560-50-F