[Federal Register Volume 61, Number 146 (Monday, July 29, 1996)]
[Rules and Regulations]
[Pages 39347-39351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19082]
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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
[[Page 39348]]
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) LD50: 9.3 g/kg, Toxicity Category
IV.
Acute Dermal, Rabbit: LC50 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 g/plate (non-
activation) and concentrations of 0, 0.1, 1.0, 10.0, 100 or 500
g/plate activation) [1,000 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
[[Page 39349]]
should have been assayed. In an in vitro chromosomal aberration assay,
norflurazon did not cause a clastogenic response at doses of 63 to 500
g/ml in the absence of liver S-9 and at doses of 125 to 1,000
g/ml in the presence of S-9. In an in vitro unscheduled DNA
synthesis assay, norflurazon at doses ranging from 1 to 333 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.="" [[page="" 39350]]="" 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:="">ocket@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
[[Page 39351]]
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
* * * * *
------------------------------------------------------------------------
[FR Doc. 96-19082 Filed 7-26-96; 8:45 am]
BILLING CODE 6560-50-F
