[Federal Register Volume 59, Number 56 (Wednesday, March 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6838]
[[Page Unknown]]
[Federal Register: March 23, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 3F2966, 1F4011, 3F4232/R2046; FRL 4763-6]
RIN 2070-AB78
Pesticide Tolerances for Acetochlor
AGENCY: Environmental Protection Agency (EPA).
Action: Final rule.
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SUMMARY: This document establishes tolerances for the combined residues
of the herbicide acetochlor (2-chloro-2`-methyl-6-ethyl-N-
ethoxymethylacetanilide) and its metabolites containing the ethyl
methyl aniline (EMA) moiety and the hydroxyethyl methyl aniline (HEMA)
moiety, to be analyzed as acetochlor, and expressed as acetochlor
equivalents in or on the raw agricultural commodities (RACS) field
corn, grain at 0.05 parts per million (ppm); field corn, forage at 1.0
ppm, and field corn fodder at 1.5 ppm, soybean grain at 0.1 ppm,
soybean forage at 0.7 ppm, soybean hay at 1.0 ppm, wheat forage at 0.5
ppm, wheat straw at 0.1 ppm, sorghum forage at 0.1 ppm, and sorghum
fodder at 0.1 ppm. These rules were requested by the Acetochor
Registration Partnership and establish the maximum level for residues
of the herbicide in or on these raw agricultural commodities.
EFFECTIVE DATE: These regulations become effective March 23, 1994.
ADDRESSES: Written objections and hearing requests, identified by the
document control number (PP 3F2966, 1F4011, 3F3242/R2046) may be
submitted to the 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 document control 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 a copy of
objections and hearing request 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 360277M,
Pittsburg, PA 15251.
FOR FURTHER INFORMATION CONTACT: By mail, Robert J. Taylor, Product
Manager (PM) 25, Registration Division (H7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm 241, CM #2, 1921
Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6800.
SUPPLEMENTARY INFORMATION: In the Federal Register of November 30, 1983
(48 FR 4116), EPA issued a notice that announced that Monsanto Co.,
1101 17th St., NW., Washington DC 20036, had submitted a petition (PP
3F2966) proposing to establish tolerances under section 408 of the
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a, for residues of
the herbicide acetochlor (2-chloro-N-(ethoxymethyl)-6-ethyl-o-
acetochloride) which proposed tolerances in or on the following raw
agricultural commodities: corn fodder and grain at 0.1 part per million
(ppm); corn forage and fodder at 0.8 ppm; eggs, milk, and tissue of
beef, chicken and hogs at 0.02 ppm; peanuts (hulls) at 2.5 ppm; peanuts
(nuts) at 0.4 ppm; soybeans (forage) at 5.0 ppm; soybeans (grain) at
0.4 ppm; soybeans (hay) at 5.0 ppm; grain sorghum (fodder) at 3.0 ppm;
grain sorghum (forage) at 3.0 ppm; and grain sorghum at 0.2 ppm.
In the Federal Register of March 11, 1992 (57 FR 8658), EPA issued
a notice that stated that ICI Americas, Inc., Agricultural Products,
Wilmington, DE 19897, submitted a petition (1F4011) which proposed to
amend 40 CFR part 180 by establishing a regulation to permit combined
residues of the herbicide acetochlor, 2-chloro-N-(ethoxymethyl)-N-
(ethyl-6-methylphenyl)acetamide in or on corn grain at 0.05 ppm, corn
forage at 1.0 ppm, and corn fodder at 1.5 ppm. ICI subsequently changed
its name to Zeneca Ag Products.
In the Federal Register of October 21, 1993 (58 FR 54354), EPA
issued a notice that announced that Zeneca Ag Products, P.O. Box 751,
Wilmington, DE 19897, submitted a petition (3F4232) proposing to amend
40 CFR part 180 by establishing a regulation to permit residues of
acetochlor and its metabolites containing the ethyl methyl aniline
(EMA) moiety and the hydroxy ethyl methyl aniline (HEMA) moiety, to be
analyzed as acetochlor, and expressed as acetochlor equivalents, in or
on the raw agricultural commodities soybean grain at 0.1 ppm, soybean
forage at 0.7 ppm, soybean hay at 1.1 ppm, wheat forage at 0.5 ppm,
wheat straw at 0.1 ppm, sorghum forage at 0.1 ppm, sorghum fodder at
0.1 ppm, sorghum silage at 0.05 ppm and sorghum hay at 0.2 ppm.
No comments were received in response to the notices of filing.
Monsanto Co. and Zencea Ag Products formed a partnership,
Acetochlor Registration Partnership (ARP). The ARP revised PP 3F2966
and PP 1F4011 by proposing the establishment of tolerances for residues
of acetochlor and its metabolites containing the ethylmethyl aniline
(EMA) moiety and the hydroxy ethyl methyl aniline (HEMA) moiety to be
analyzed as acetochlor, and expressed as acetochlor equivalents in or
on the raw agricultural commodities field corn grain at 0.05 ppm, field
corn forage at 1.0 ppm, and field corn fodder at 1.5 ppm.
The company name for the filing notice of October 21, 1993 (58 FR
54354) should have read Acetochlor Registration Partnership instead of
Zeneca Ag Products. During the course of review, it was determined that
the proposal for PP 3F4232 needed further clarifications. The ARP
amended PP 3F44232 by proposing the establishment of tolerances for
residues of acetochlor and its metabolites containing the ethyl methyl
aniline (EMA) moiety and the hydroxy ethyl methyl aniline (HEMA) moiety
to be analyzed as acetochlor, and expressed as acetochlor equivalents,
in or on the raw agricultural commodities soybean grain at 0.1 ppm,
soybean forage at 0.7 ppm, soybean hay at 1.0 ppm, wheat grain at 0.02
ppm, wheat forage at 0.5 ppm, wheat straw at 0.1 ppm, wheat forage at
0.1 ppm, sorghum grain at 0.02 ppm, sorghum forage at 0.1 ppm, sorghum
fodder at 0.1 ppm, sorghum silage at 0.05 ppm, and sorghum hay at 0.2
ppm. The forthcoming update of Table II of the Residue Chemistry
Guidelines will not list sorghum silage and sorghum hay as commodities
requiring residue data. Therefore, the tolerance proposals of sorghum
silage at 0.05 ppm and sorghum hay at 0.2 ppm are being withdrawn,
since establishment of tolerances on these commodities is not
necessary.
Because the tolerances on wheat grain at 0.02 ppm and sorghum grain
at 0.02 ppm were not previously published, EPA will soon publish in the
Federal Register a notice of the ARP's petition to establish these
tolerances. This document will allow 30 days for public comment on the
regulated wheat grain and sorghum tolerances. All other revisions to
pesticide petitions 3F2966, 1F4011, and 3F4232 by the ARP involved
clarifications of recent rewording of previously published proposals or
minor changes, e.g., lowering the soybean hay tolerance to 1.0 ppm from
1.1 ppm; therefore, no additional period of public comment is needed.
The data submitted in the petitions and other relevant material
have been evaluated. The acetochlor toxicological data listed below
were considered in support of these tolerances.
1. Acute toxicology data submitted place technical acetochlor in
toxicity category II for eye irritation, toxicity III for acute oral,
acute dermal, and acute inhalation. Technical acetochlor is in category
IV for primary skin irritation and is a skin sensitizer.
2. A 3-month feeding study submitted by Monsanto with rats fed
dosages of 0, 40, 100, and 300 milligrams /kilograms/day (mg/kg/day)
resulted in a no-observed-effect-level (NOEL) of 40 mg/kg/day based on
loss of body weight and decreased food consumption at 100 mg/kg/day.
3. A 3-week dermal study submitted by Monsanto with rabbits fed
dosages of 0, 100, 400, and 1,200 mg/kg/day resulted in a NOEL for
systemic effects of 6,400 mg/kg/day based on mortality and decreased
body weight at 1,200 mg/kg/day, (HDT). The lowest effect level (LEL)
for dermal irritation was 100 mg/kg lowest dose test (LDT). A NOEL for
dermal irritation was not established.
4. A 3-week dermal study submitted by ICI with rats fed dosages of
0.1, 1.0, 10, or 100 mg/kg/day resulted in minimal to mild skin
irritation after 21 days. Signs of systemic toxicity were not apparent
at any level. Higher doses were not possible because of severe dermal
toxicity at higher doses.
5. In a 1-year feeding study submitted by Monsanto, with dogs fed
dosages of 0, 4, 12, and 40 mg/kg/day, the NOEL was 12 mg/kg/day based
on decreased body weight gains in males, decreased terminal body weight
in females, testicular atrophy with accompanying decreases in absolute
and relative testicular weight, increase in relative liver weights in
male and females, and clinical chemistry changes at 40 mg/kg/day (HDT).
6. In a 1-year feeding study submitted by ICI, with dogs fed
dosages of 0, 2, 10, and 50 mg/kg/day, the NOEL was 2 mg/kg/day based
on increased salivation, ornithine carbamyl transferase, and
triglyceride values accompanied by decreased blood glucose levels and
liver glycogen levels at 10 mg/kg/day. Interstitial nephritis, tubular
degeneration of the testes and hypospermia were reported.
7. In a developmental study submitted by Monsanto, with rats fed
dosages of 0, 50, 200, and 400 mg/kg/day, acetochlor did not induce
developmental toxicity in rats up to 400 mg/kg/day (HDT). The maternal
NOEL was 200 mg/kg/day based on matting and/or staining of the
anogenital region, a decrease in mean maternal weight gain during the
treatment period, and in adjusted mean weight gain on gestation day 20
at 400 mg/kg/day (HDT).
8. In a developmental study submitted by ICI, with rats fed dosages
of 0, 40, 150, and 600 mg/kg/day, the developmental NOEL was 150 mg/kg/
day based on increased resorptions, post-implantation loss, and
decrease in mean fetal weight at 600 mg/kg/day (HDT). The maternal
toxicity for this study was 150 mg/kg/day based on animals sacrificed
moribund, clinical observations, and decreased body weight gain at 600
mg/kg/day (HDT).
9. In a developmental study submitted by Monsanto, with rabbits fed
dosages of 0, 15, 50, and 190 mg/kg/day, (females) acetochlor did not
induce developmental toxicity in rabbits up to 190 mg/kg/day (HDT). The
maternal toxicity NOEL was 50 mg/kg/day based on loss of body weight
during dosing at 190 mg/kg/day (HDT).
10. In a developmental study subbmitted by ICI, with rabbits fed
dosages of 0, 30, 100, and 300 mg/kg/day, acetochlor did not induce
either maternal or developmental toxicity up to 300 mg/kg/day (HDT).
11. In a two-generation reproduction study submitted by Monsanto,
with rats fed dosages of 0, 30.4, 74.1, and 324.5 mg/kg/day (males) or
0, 44.9, 130.1, and 441.5 mg/kg/day (females), the reproductive NOEL
was 30.4 mg/kg/day for males and 44.9 mg/kg/day for females, based on
decreased body weight gain of F2b pups at 74.1 mg/kg/day for males and
130.1 mg/kg/day for females. A NOEL for systemic effects was not
established.
12. In a two-generation reproduction study submitted by ICI, with
rats fed dosages of 0, 1.6, 21, and 160 mg/kg/day, the reproductive
NOEL was 21 mg/kg/day based on significant reductions in pup weight at
lactational day 21 and total body weight gain during lactation at 160
mg/kg/day (HDT). The parental NOEL was 21 mg/kg/day based on reductions
in body weight, accompanied by slight reductions in food consumption
and significant increases in relative organ weights at 160 mg/kg/day
(HDT).
13. In a chronic feeding/carcinogenicity study submitted by
Monsanto with mice fed dosages of 0, 75, 225, and 750 mg/kg/day
carcinogenic effects noted included increased incidence of liver
carcinomas in high-dose males, total lung tumors in females at all dose
levels, carcinomas of lungs in females fed 75 and 750 mg/kg/day,
uterine histiocytic sarcomas in females at all dose levels, and total
benign ovarian tumors in mid-dose females. Other dose-related changes
included (1) increased mortality and decreased mean body weights in
both high-dose males and females, (2) decreased red blood cell count,
hematocrit, and hemoglobin in high-dose females at terminal sacrifice,
(3) increased white blood count in high-dose males at terminal
sacrifice, (4) increased platelet count in mid- and high-dose females
at terminal sacrifice, (5) increased mean liver weight and liver-to-
body-weight ratios at study termination in all dose groups of males and
in high-dose females; increased absolute and relative kidney weights in
all dose groups of males at termination; increased absolute and
relative adrenal weights in all groups of males and in high-dose
females at study termination; and (6) increased interstitial nephritis
in high-dose males and females.
14. In a chronic feeding/carcinogenicity study submitted by ICI
with mice fed dosages 0, 1.1, 11, and 116 mg/kg/day in males and 0,
1.4, 13, and 135 mg/kg/day in females, carcinogenic effects noted
included an increase in pulmonary adenoma in both male and females at
the high dose. Pulmonary tumors were confirmed as adenomas or
carcinomas of the lung parenchyma and were all of the alveolar type.
The NOEL for systemic toxicity in females was 13 mg/kg/day based on a
significant increase in anterior polar vacuoles in the lens of the eye
at 135 mg/kg/day.
15. In a chronic feeding/carcinogenicity study submitted by
Monsanto, with rats fed dosages of 0, 22, 69, and 250 mg/kg/day (males)
or 0, 30, 93, and 343 mg/kg/day (females), carcinogenic effects noted
at 250 mg/kg/day in males and 343 mg/kg/day in females included
hepatocellular carcinoma in both sexes and thyroid follicular cell
adenoma in males. Nasal papillary adenomas were noted in male rats at
69 mg/kg/day and above and in females at 93 mg/kg/day. A NOEL for
chronic effects was not established.
16. In a repeat chronic feeding/carcinogenicity study submitted by
Monsanto, in rats fed dosages of 0, 2, 10, and 50 mg/kg/day oncogenic
effects noted at 50 mg/kg/day (HDT) included neoplastic nodules of the
liver, follicular adenoma/cystadenoma of the thyroids and papillary
edema of the mucosa of the nose/turbinates in high dose animals. The
NOEL for chronic effects was 10 mg/kg/day based on decreased body
weights and body weight gain in both sexes, high cholesterol levels in
males, increased absolute and relative kidney and liver weight in
males, and increased testicular weights at 50 mg/kg/day (HDT).
17. In a 2-year chronic feeding/carcinogenicity study submitted by
ICI, with rats fed dosages of 0, 0.8, 7.9, and 79.6 mg/kg/day,
carcinogenic effects noted at 79.6 mg/kg/day (HDT) included a
significant increase in nasal epithelial adenomas and thyroid
follicular cell adenomas in both sexes at 79.6 mg/kg/day. Also, at that
dose nasal carcinoma was present in two males and one female rat at
this dose. Rare tumors in the form of benign chondroma of the femur and
basal cell tumor of the stomach were also observed at 79.6 mg/kg/day.
The systemic NOEL was 7.9 mg/kg/day based on decreased body weight
gain, decreased food efficiency, increased organ to body weight ratios,
increased plasma GGT and cholesterol at 79.6 mg/kg/day (HDT).
18. In mutagenicity testing, submitted by Monsanto, acetochlor was
weakly positive in the CHO/HGPRT gene mutation assay with and without
activation in the mouse lymphoma assay. Acetochlor was negative in a
DNA damage repair assay in rat hepatocytes, a Salmonella assay, and two
(2) in vivo chromosomal aberration studies.
19. In mutagenicity tests conducted by ICI, acetochlor induced a
reproducible, positive, mutagenic response in strain TA 1538 of
Salmonella typhimurium with metabolic activation at 100 ug/plate
(however, this was less than the 2 X background mutation, but was
significant at p less than 0.05). Significant increases in number of
revertant colonies were not induced in strains TA 1535, TA 1537, TA98,
and TA100. Acetochlor was not clastogenic in a mouse micronucleus test
at doses tested (898 and 1,436 mg/kg in males; 1,075 and 1,719 mg/kg in
females). Acetochlor was clastogenic in cultured human lymphocytes both
in the presence and absence of 59 mix at 100 ug/ml, and in the absence
of 59 mix at 50 ug/ml. Acetochlor induced a weak DNA repair (measured
by UDS) in rat hepatocytes derived from animals exposed in vivo at
2,000 mg/kg. In a structural chromosome aberration study, acetochlor at
doses 1,000 and 2,000 mg/kg resulted in reduced fertility during weeks
2, 3, and 4 of this study, as shown by reduced pregnancy incidence,
decreased implants per pregnancy incidence, increased preimplantion
loss, and loss, and decreased time implant per pregnancy. Early late
intrauterine deaths were not affected in this study. There was positive
evidence of mutagenicity at the mid- and high-dose levels in this
study.
Available testing for acetochlor by Monsanto was referred to the
Toxicology Branch Peer Review Committed (PRC) for evaluation on
September 12, 1985. Based on available information, the PRC classified
acetochlor as a B2 Carcinogen-Probable Human Carcinogen for the
following reasons.
1. Increased incidence in rats of hepatocellular carcinomas in both
sexes and thyroid follicular cell adenomas in males.
2. An increased incidence in mice of hepatocellular carcinomas in
both sexes, lung carcinomas, uterine histiocytic sarcomas, benign
ovarian tumors, and kidney adenomas in females.
3. Positive mutagenic data in the CHO/HGPRT and mouse lymphoma
assays.
4. Positive carcinogenicity data on structural analogues, alachlor,
butachlor, and metolachlor.
After review of the repeat chronic feeding/oncogenicity study in
rats and reevaluation of slides from the original rat study, the Health
Effects Division Peer Review Committee met February 8, 1989, to discuss
acetochlor with special reference to its carcinogenic potential for
causing nasal tumors. The PRC cited an increased incidence of nasal
adenomas in rats in (2) studies and a stronger analogy to alachlor
which also causes tumors. The PRC reaffirmed the classification of
acetochlor as a B2 carcinogen (probable human carcinogen) and
recommended that the quantitative risk assessment (Q*1) be based
on the data on nasal turbinate papillary adenomas in male and female
rats.
Results of the peer reviews were referred to the FIFRA Scientific
Advisory Panel (SAP) on September 28, 1989. The SAP agreed that
acetochlor should be classified as a B2 carcinogen.
Available testing for acetochlor, submitted by ICI, was referred to
the Health Effects Division Peer Review Committee on October 16, 1991,
for discussion and evaluation of the weight-of-the-evidence on
acetochlor with particular reference to its carcinogenic potential. The
PRC agreed that acetochlor should be classified as a Group B2--Probable
Human carcinogen. This was consistent with earlier decisions based on
Monsanto data. The combined data strengthens the Group B2
classification. The committee noted that the two data bases on
acetochlor from two different registrants were in close agreement with
each other concerning the major tumor types.
For the purpose of risk characterization for acetochlor, a low-dose
extrapolation model applied to the experimental animal tumor data was
used for quantification of human risk (Q1*). For quantification,
the Committee recommended separate calculations for both sexes of rats
using the combined incidence for nasal tumors for each sex. The
separate values were then combined using appropriate statistical
methods.
The RfD was based on a NOEL of 2.0 mg/kg/day established in a 1-
year feeding study with dogs (ICI) and using an uncertainty factor of
100 is calculated to be 0.02 mg/kg/day. The theoretical maximum residue
contribution (TMRC) for the general U.S. population for corn uses is
1.7 X 10-3 mg/kg/day or 0.1% of the RfD. The TMRC for the soybean,
sorghum and wheat rotational crop tolerance is 1.1 X 10-4 mg/kg/
kwt/day or 0.5% of the RfD. The total TMRC for all crop tolerances for
the general U.S. population is 1.3 X 10-4 mg/kg kwt/day or 0.6% of
the RfD. For the mostly highly exposed subgroup, nonnursing infants
less than 1 year old, the TMRC from the corn uses and rotational crop
uses is 4.9 X 10-5 mg/kg kwt/day (0.2% of RfD) and 3.6 X 10-4
mg/kg kwt/day (2% of the RfD) respectively, for a total of 4.1 X
10-4 mg/kg kwt/day or 2% of the RfD. TMRC is calculated assuming
that residues are at the established tolerances or at maximum residue
limits if the tolerances do not include all metabolites and that 100
percent of the corn crop is treated with acetochlor and that the
rotational crops would all be grown in fields where acetochlor-treated
corn has been grown. The TMRC discussed here include the commodities
wheat grain and sorghum grain being proposed elsewhere in this issue of
the Federal Register.
Based on a Q*1 of 0.017 mg/kg/day, the upper-bound lifetime
cancer risk was calculated to be 2.9 X 10-7 for field corn
tolerances and 1.9 X 10-6 for the rotational crop tolerances. The
upper-bound carcinogenic risk from corn and the rotational crop
tolerances (including sorghum grain and wheat grain which are proposed
elsewhere in this issue of the Federal Register) was calculated to be
2.2 X 10-6.
Data lacking include an unscheduled DNA synthesis in rat
hepatocytes (in vivo exposure and in vitro culture) for metabolite 57,
and a cytogenetics assay for aberrations using cultured human
lymphocytes for metabolite 57. The petitioner has been notified of
these deficiencies and has agreed to submit the studies.
There are currently no regulations against the registration of this
chemical for use on corn. Even though acetochlor is classified as a B2-
carcinogen, EPA believes that the establishment of these tolerances
will not pose an unreasonable risk to humans as a result of dietary
exposure. The establishment of these tolerances utilize less than 1%
(0.6%) of the RfD. The upper bound carcinogenic risk of 2.2 X 10-6
is in the range of 1 X 10-6, a level generally presumed to be no
greater than a negligible risk. Morever, this estimate is considered
worst-case, and it probably overestimates the dietary cancer risk. It
is unlikely that the following assumptions made by the Agency, namely,
(1) that residues will be at the establised tolerances levels, (2) that
100 percent of the corn crop will be treated with acetochlor, and (3)
that all rotational crops will be grown where acetochlor treated corn
has been grown, are actually the case.
The pesticide is useful for the purpose for which tolerances are
sought. The nature of the residue is adequately understood for the
purposes of establishing these tolerances. Adequate analytical
methodology (high-pressure liquid chromotography (HPLC) using an
oxidative coulometric electrochemical detector (OCED)is available for
enforcement purposes. Because of the long lead-time from establishing
tolerances to publication, the enforcement methodology is being made
available in the interim to anyone interested in pesticide enforcement.
Request by mail from Calvin Furlow, Public Response and Program
Tesources 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. 1130A,
CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. No detectable
secondary residues are expected in milk; eggs; meat, fat, or meat
byproducts of cattle, goats, hogs, horses, sheep or poultry.
Based on the data and the information cited above, the Agency has
determined that the establishment of tolerances by amending 40 CFR part
180 will protect the public health. Therefore, EPA is establishing the
tolerances as described below.
Any person adversely affected by this regulation may, within 30
days after publication of this document in the Federal Register, file
written objections and/or request for a hearing 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 factual issue(s) on which a hearing is requested, the
requestor`s contentions on each such issue, 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 Adminstrator determines that the
material submitted shows the following; there is a 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.
The Office of Management and Budget has exempted this rule from the
requirements of section 3 of Executive Order 12866. Pursuant to the
requirements of the Regulatory Flexibility Act (Pub. L 96-354, 94 Stat.
1164, 5 U.S.C. 601-612), the Administrator has determined that
requlations establishing new tolerances or food additive regulations or
establishing exemptions from tolerance requirements do not have a
significant economic impact on a substanial number of small entities. A
certification statement of this effect 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: March 11, 1994.
Douglas D. Campt,
Director, Office of Pesticide Programs.
Therefore, 40 CFR part 180 is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. By adding a new Sec. 180.470, to read as follows:
Sec. 180.470 Acetochlor; tolerances for residues.
Tolerances are established for residues of acetochlor, 2-chloro-2`-
methyl-6-ethyl-N-ethoxymethylacetanilide, and its metabolities
containing the ethyl methyl aniline (EMA) moiety and the hydroxyethyl
methyl aniline (HEMA) moiety, to be analyzed as acetochlor, and
expressed as acetochlor equivalents, in or on the following raw
agricultural commodities.
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Field corn, fodder......................................... 1.5
Field corn, forage......................................... 1.0
Field corn, grain.......................................... 0.05
Sorghum, fodder............................................ 0.1
Sorghum, forage............................................ 0.1
Soybean, forage............................................ 0.7
Soybean, grain............................................. 0.1
Soybean, hay............................................... 1.0
Wheat, forage.............................................. 0.5
Wheat, straw............................................... 0.1
------------------------------------------------------------------------
[FR Doc. 94-6838 Filed 3-22-94; 8:45 am]
BILLING CODE 6560-50-F
