[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