Document ID: EPA-HQ-OPP-2008-0529-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2010-01-06T05:00Z

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

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[EPA–HQ–OPP–20[08]–[0529]; FRL–XXXX–X]

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RIN 2070–[Tolerances are exempt, unless proposed by EPA. If proposed,
use the proposed rule’s RIN.]

[Laminarin]; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of [laminarin in or] on [all food
commodities] when applied preharvest [as a biochemical pesticide to
stimulate natural defense mechanisms in plants]. [Laboratoires Goëmar
SA c/o SciReg, Inc.] submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of [laminarin].

DATES: This regulation is effective [insert date of publication in the
Federal Register]. Objections and requests for hearings must be received
on or before [insert date 60 days after date of publication in the
Federal Register], and must be filed in accordance with the instructions
provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY
INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA–HQ–OPP–20[08]–[0529]. All
documents in the docket are listed in the docket index available at
http://www.regulations.gov. Although listed in the index, some
information is not publicly available, e.g., Confidential Business
Information (CBI) or other information whose disclosure is restricted by
statute. Certain other material, such as copyrighted material, is not
placed on the Internet and will be publicly available only in hard copy
form. Publicly available docket materials are available in the
electronic docket at http://www.regulations.gov, or, if only available
in hard copy, at the OPP Regulatory Public Docket in Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305–5805.

FOR FURTHER INFORMATION CONTACT: [Chris Pfeifer], Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone
number: [703-308-0031]; e-mail address:
[pfeifer.chrispfeifer.chris]@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

	You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:

 Crop production (NAICS code 111).

	• Animal production (NAICS code 112).

	• Food manufacturing (NAICS code 311).

	• Pesticide manufacturing (NAICS code 32532).

	This listing is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining whether
this action might apply to certain entities. If you have any questions
regarding the applicability of this action to a particular entity,
consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Electronic Access to Other Related Information?

	You may access a frequently updated electronic version of 40 CFR part
180 through the Government Printing Office's e-CFR site at
http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

	Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. The EPA procedural regulations, which
govern the submission of objections and requests for hearings, appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA–HQ–OPP–20[08]–[0529] in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk on or before [insert date 60
days after date of publication in the Federal Register].

	In addition to filing an objection or hearing request with the Hearing
Clerk as described in 40 CFR part 178, please submit a copy of the
filing that does not contain any CBI for inclusion in the public docket
that is described in ADDRESSES. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior
notice. Submit your copies, identified by docket ID number
EPA–HQ–OPP–20[08]–[0529], by one of the following methods.

  Federal eRulemaking Portal: http://www.regulations.gov. Follow the
on-line instructions for submitting comments.

	• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket
(7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001.

	• Delivery: OPP Regulatory Public Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries are only accepted during the
Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays). Special arrangements should
be made for deliveries of boxed information. The Docket Facility
telephone number is (703) 305–5805.

II. Background and Statutory Findings

	In the Federal Register of [July 31, 2008] ([73] FR [44719])
(FRL–8374–3), EPA issued a notice pursuant to section 408(d)(3) of
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
tolerance petition (PP [7E7276]) by [Laboratoires Goëmar SA c/o SciReg,
Inc.], [12733 Director’s Loop, Woodbridge, VA 22192]. The petition
requested that 40 CFR part 180 be amended by establishing an exemption
from the requirement of a tolerance for residues of [laminarin]. A
summary of the petition prepared by the petitioner [Laboratoires Goëmar
SA c/o SciReg, Inc.] was included in the docket for this action. [There
were no comments received in response to the notice of filing].

	Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption
from the requirement for a tolerance (the legal limit for a pesticide
chemical residue in or on a food) only if EPA determines that the
exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines
“safe” to mean that “there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.” This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to “ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....” Additionally, section 408(b)(2)(D) of FFDCA requires that
the Agency consider “available information concerning the cumulative
effects of a particular pesticide's residues” and “other substances
that have a common mechanism of toxicity.”

	EPA performs a number of analyses to determine the risks from aggregate
exposure to pesticide residues. First, EPA determines the toxicity of
pesticides. Second, EPA examines exposure to the pesticide through food,
drinking water, and through other exposures that occur as a result of
pesticide use in residential settings.

III. Toxicological Profile

	Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness, and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.

β-glucans—particularly laminarin in this case—without documented
toxicological effects, the data submitted to the Agency, in conjunction
with and in support of this tolerance exemption, confirm that laminarin
is virtually nontoxic and poses no dietary risks to humans.  

Because laminarin is considered “toxicologically innocuous,” no
residue studies are required to support a tolerance exemption. However,
laminarin’s low toxicity profile notwithstanding, another
justification for this exemption from the requirement of a tolerance is
the unlikelihood of residues for this biochemical pesticide in or on
food. Laminarin is intended for application as a systemic acquired
resistance (SAR) inducer—a preventative mode of action. As such, it is
applied early in a crop’s life cycle—in its growing stages—to help
build immunity to disease organisms such as mold and bacterial
infection. Furthermore, as a biochemical, it is prone to biodegrade
rapidly. Data indicate that the active ingredient is more than 65%
biodegraded after two weeks (Master Record Identification Number (MRID
No.) 472649-54). Calculations indicate that it would be fully
biodegraded long before any consumption would occur because the most
likely final application of the pesticide would occur early in the
growing season for plants treated with this pesticide. Accordingly, no
exposures beyond background levels are expected. 

	Summaries of the toxicological data submitted in support of this
exemption from the requirement of a tolerance follow: 

A.	Acute Toxicity:  Acute toxicity studies, submitted to support the
registration of the end-use product containing laminarin, confirm a low
toxicity profile and buttress the finding that this active ingredient
poses no significant human health risk with regard to new food uses.
Altogether, the acute toxicity data show virtual nontoxicity for all
routes of exposure and suggest that any dietary risks associated with
this carbohydrate would be negligible.

1.  The acute oral median lethal doses (LD50s) in rats were greater than
2,000 milligrams per kilogram (mg/kg) and confirmed negligible toxicity
through the oral route. There were no observed toxicological effects on
the test subjects in either of the two acute oral studies submitted
(Master Record Identification Numbers (MRID Nos.) 472649-30 and
472649-73).  Laminarin is Toxicity Category III for acute oral toxicity.
 

2.	The acute dermal median lethal dose (LD50) in rats was greater than
5,000 mg/kg. These data substantiated laminarin’s relative dermal
nontoxicity to the general public (MRID Nos. 472649-31 and 472649-74). 
Laminarin is Toxicity Category IV for acute dermal toxicity.    

3.	The acute inhalation median lethal concentration (LC50) was greater
than 1.02 milligrams per liter (mg/L) in rats and showed no significant
inhalation toxicity (MRID No. 472649-32).  Laminarin is Toxicity
Category III for acute inhalation toxicity.

4.	A skin irritation study on rabbits indicated that laminarin was not
irritating to the skin (MRID No. 472649-34).  Laminarin is Toxicity
Category IV for dermal irritiation.

5.	Data indicated laminarin is not a dermal sensitizer (MRID Nos.
472649-35 and 472649-78).  

	Data indicate that laminarin is not acutely toxic.  No toxic endpoints
were established in any of the acute toxicity studies; and no
significant toxicological effects were observed in any of the acute
toxicity studies.

B.	Mutagenicity:  Three mutagenicity studies, using laminarin as the
test substance, were performed. These studies are sufficient to confirm
that there are no expected dietary or non-occupational risks of
mutagenicity with regard to new food uses.

1.	The Reverse Mutation Assay (MRID No. 472649-42) showed that laminarin
did not induce mutant colonies relative to control groups. 

2.	The In vitro Mammalian Cells in Culture Assay (MRID No. 472649-43)
demonstrated that laminarin did not damage chromosomes or the mitotic
apparatus of bone marrow cells. 

3.	A Bone Marrow Micronucleus Assay (MRID No. 472649-44) indicated that
no toxicity was noted in either sex at any dose up to the limit dose of
2,000 mg/kg.

C.	Subchronic Toxicity:  Based on its biodegradation properties,
residues of laminarin are not expected to result in significant dietary
exposure beyond the levels expected in background dietary exposures.
Nonetheless, three subchronic oral toxicity studies satisfied the data
requirements for subchronic toxicity and indicated that laminarin has no
subchronic toxicological effect.  

1.	A 28-day Oral Toxicity Study (MRID No. 472649-37) found no
toxicological effects regarding mortality, clinical observations,
neurotoxicity assessment, body weight, food consumption, hematology,
clinical chemistry, organ weights, and macroscopic or microscopic
observations. The no observable effect level (NOEL) was determined to be
1,000 milligrams per kilogram per day (mg/kg/day). 

2.	A 90-day Oral Toxicity Study (MRID No. 472649-38) found no
statistical difference in hematology, clinical chemistry, or urinalysis
between test subjects and the control. The NOAEL was determined to be
1,000 mg/kg/day.  

3.	Another 90-day Oral Toxicity Study (MRID No. 472649-39) also found no
statistical difference in hematology, clinical chemistry, or urinalysis
between test subjects and the control. The NOAEL was again determined to
be 1,000 mg/kg/day.

D.	Developmental Toxicity:  The data submitted to the Agency demonstrate
a clear lack of developmental toxicity and supports the Agency’s
conclusion that there is no risk of developmental toxicity associated
with new food uses. Data submitted to the Agency satisfy the data
requirements for developmental toxicity and indicate that laminarin
poses negligible risk with regard to developmental toxicity.

1.	A Prenatal Developmental Toxicity Study (MRID No. 472649-40) found no
significant treatment-related reproductive effects or fetal
abnormalities and established a no observable adverse effect level
(NOAEL) of 1,000 mg/kg/day.  

2.	A second Prenatal Developmental Toxicity Study (MRID No. 472649-41)
also found no significant treatment-related reproductive effects or
fetal abnormalities and confirmed a NOAEL of 1,000 mg/kg/day.

E.	Effects on Endocrine Systems:  There is no available evidence
demonstrating that laminarin is an endocrine disruptor in humans. As a
result, the Agency is not requiring information on the endocrine effects
of laminarin at this time. However, the Endocrine Disruption Screening
Program (EDSP) has established a protocol, which guides the Agency in
selecting suspect ingredients for review, and the Agency reserves the
right to require new information should the program require it.
Presently, based on the lack of exposure and the negligible toxicity
profile of laminarin, no adverse effects to the endocrine are known or
expected. Overall, the lack of evidence of endocrine disruption is
consistent with laminarin’s low toxicity profile and supports this
exemption from the requirement of a tolerance.]

IV. Aggregate Exposures

	In examining aggregate exposure, section 408 of FFDCA directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from ground water or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).

A. Dietary Exposure

	[Because of laminarin’s ability to biodegrade relatively quickly and
the typical time during plant growth that it will be applied, the Agency
does not anticipate many residues being present in or on food at the
time of consumption.  Moreover, any residues that are present in or on
food at the time of consumption as a result of pesticide use are likely
to be indistinguishable from naturally occurring laminarin due to its
natural occurrence and ubiquitous presence in foods and dietary
supplements.  Finally, the Agency believes that it is unlikely that any
exposure to the residues of laminarin will result in dietary risks
because of the nontoxic mode of action as a SAR inducer and the
pesticide’s negligible toxicity profile.]

	1. Food. [Exposure to residues of laminarin on foods is expected to be
negligible. Data submitted to the Agency show that laminarin is 65% to
71% biodegraded within two weeks, and that it hydrolyzes very rapidly
into glucose. Because applications necessarily occur early in the
growing season (due to its mode of action as a SAR inducer), and given
its short-lived presence on crops, no significant pesticidal residues
are anticipated for harvested foods. However, in the event of exposure
to residues of laminarin, no dietary risks are anticipated. As described
in Unit III, acute, subchronic, mutagenic and developmental studies
support its nontoxic profile. Furthermore, it is already present in
foods without any known detrimental effects. Indeed, there is no
information in the public literature suggesting any health issues to
either animals or plants relative to this compound. Lastly, proposed
rates of application of laminarin will result in substantially fewer
residues in or on foods as a result of pesticide application than the
quantities of laminarin already consumed in foods and those allowed in
dietary supplements. In sum, no dietary exposure is expected; however,
any potential dietary exposures would not be expected to pose any
quantifiable risk, mainly due to laminarin’s nontoxic profile.]

	2. Drinking water exposure. [Residues of laminarin are not expected to
be present in drinking water as applications of laminarin are made
directly to terrestrial crops. Laminarin residues are not expected to
percolate through the soil because residues are not expected to persist
beyond the time it would typically take for any residues to percolate
into the groundwater. In the event of errant spray drift or
extraordinary rainfall, laminarin will not persist in water due to its
rapid hydrolyzation into glucose. Moreover, given laminarin’s nontoxic
profile as described in Unit III, risks from miniscule aquatic exposure
would be negligible. Altogether, drinking water exposure is not expected
to pose any quantifiable risk due to both a lack of residues and the
nontoxicity of laminarin.] 

B. Other Non-Occupational Exposure

	[Non-occupational exposure is not expected because lamarin is not
approved for residential uses. The active ingredient is applied directly
to commodities and degrades rapidly. Furthermore, the Agency notes that
health risks are not expected from any pesticidal exposure to this
active ingredient, no matter the circumstances. An August 2009 Agency
risk assessment of laminarin clearly establishes that even prolonged and
regular occupational exposures, which are associated with this active
ingredient, pose negligible risks. Laminarin is characterized by its
biodegradability, low toxicity profile, nontoxic, SAR-inducing mode of
action, and demonstrable lack of dietary effects.]

	1. Dermal exposure. [Non-occupational dermal exposures to laminarin are
expected to be negligible because of its directed agricultural use. Even
in the event of dermal exposure to residues, the nontoxic profile of
laminarin (as described in Unit III) is not expected to result in any
risks through this route of exposure.]

	2. Inhalation exposure. [Non-occupational inhalation exposures are not
expected to result from the agricultural uses of laminarin. Any
inhalation exposure associated with this new agricultural use pattern is
expected to be occupational in nature.]

V. Cumulative Effects

[Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered available
information concerning the cumulative effects of exposure to laminarin
residues and other substances that have a common mechanism of toxicity.
These considerations include the possible cumulative effects of such
residues on infants and children.  Because laminarin operates through a
nontoxic mode of action, there is no common mechanism of toxicity
between this and any other substances; therefore, this provision does
not apply.  Nevertheless, given that no exposure to residues are
expected when applications are made in accordance with EPA-approved
labeling and good agricultural practices, and laminarin has a long
history of dietary consumption without incident, the Agency concludes
that there is no reason to anticipate cumulative effects from the
residues of this active ingredient with other related pesticides.]

VI. Determination of Safety for U.S. Population, Infants and Children

	[Health risks to humans, including infants and children, are considered
negligible with regard to the pesticidal use of laminarin. As
illustrated in Unit III, acute toxicity studies indicate that laminarin
has negligible toxicity. It is ubiquitous in nature and present in
fruits and vegetables. To date, there is no history of toxicological
incident involving its consumption and its use in food supplements is
already allowed by the United States Food and Drug Administration. Of
equal note, little to no exposure to the residues of laminarin is
expected. Pesticidal applications are applied directly to agricultural
crops, and data suggest that residues are not expected beyond the time
of harvest. Accordingly, little to no dietary exposure is expected. As
such, the Agency has determined that this food use of laminarin poses no
foreseeable risks to human health or the environment. Thus, there is a
reasonable certainty of no harm to the general U.S. population,
including infants and children, from exposure to this active ingredient.

	1. U.S. population. The Agency has determined that there is a
reasonable certainty that no harm will result from aggregate exposure to
residues of laminarin to the U.S. population. This includes all
anticipated dietary exposures and other non-occupational exposures for
which there is reliable information. The Agency arrived at this
conclusion based on the low levels of mammalian dietary toxicity
associated with laminarin, the natural ubiquity of laminarin in
foodstuffs, and information suggesting that the pesticidal use of
laminarin will not result in a significant, if any, exposure. For these
reasons, the Agency has determined that laminarin residues in and on all
food commodities will be safe, and that there is a reasonable certainty
that no harm will result from aggregate exposure to residues of
laminarin. 

	2. Infants and children. FFDCA section 408(b)(2)(C) provides that EPA
shall assess the available information about consumption patterns among
infants and children, special susceptibility of infants and children to
pesticide chemical residues, and the cumulative effects on infants and
children of the residues and other substances with a common mechanism of
toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA
shall apply an additional tenfold margin of exposure (safety) for
infants and children in the case of threshold effects to account for
prenatal and postnatal toxicity and the completeness of the database
unless the EPA determines that a different margin of exposure (safety)
will be safe for infants and children. Margins of exposure (safety),
which are often referred to as uncertainty factors, are incorporated
into EPA risk assessments either directly or through the use of a margin
of exposure analysis, or by using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk.

 Based on all the information evaluated for laminarin, the Agency
concludes that there are no threshold effects of concern and, as a
result, the provision requiring an additional margin of safety does not
apply.]   

VII. Other Considerations

A. Endocrine Disruptors

	[There is no evidence, at this time, that suggests that laminarin will
compromise the endocrine system, function in a manner similar to any
known hormone, or act as an endocrine disruptor.]

B. Analytical Method(s)

	[Through this action, the Agency proposes an exemption from the
requirement of a tolerance of laminarin when used on food commodities,
without any numerical limitations for residues. EPA has determined that
residues resulting from the pesticidal use of laminarin are unlikely,
and that there are no significant toxicity concerns in the event that
residues of the active ingredient are present. As a result, the Agency
has concluded that an analytical method is not required for enforcement
purposes for laminarin.]

C. Codex Maximum Residue Level

	[There are no codex maximum residue levels established for residues of
laminarin.]

VIII. Conclusions

	[Based on the data submitted to support this tolerance exemption, and
other information available to the Agency, EPA is establishing an
exemption from the tolerance requirements, pursuant to FFDCA section
408(c), for residues of laminarin in or on all food commodities.]

 IX. Statutory and Executive Order Reviews

	This final rule establishes a tolerance under section 408(d) of FFDCA
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is not
subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994). 

	Since tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.

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	This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this action
alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of section
408(n)(4) of FFDCA. As such, the Agency has determined that this action
will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and the
States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, the Agency has determined
that Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175, entitled Consultation and Coordination
with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not
apply to this final rule. In addition, this final rule does not impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104–4).

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⸀d) (15 U.S.C. 272 note).

X. Congressional Review Act

	The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides
that before a rule may take effect, the agency promulgating the rule
must submit a rule report to each House of the Congress and to the
Comptroller General of the United States. EPA will submit 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
United States prior to publication of this final rule in the Federal
Register. This final rule is not a “major rule” as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

	Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and
pes獴‬敒潰瑲湩⁧湡⁤敲潣摲敫灥湩⁧敲畱物浥湥獴മ
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 ________________

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	Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

	Authority: 21 U.S.C. 321(q), 346a and 371.

	2. Section 180.[insert CFR cite] is added to subpart D to read as
follows:

§ 180.[insert CFR cite] [Laminarin; Exemption from the Requirement of
a Tolerance].

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,r on all food commodities when laminarin is applied preharvest.]

[FR Doc. ??–???? Filed ??–??–??; 8:45 am]

BILLING CODE 6560–50–S

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