Document ID: EPA-HQ-OPP-2008-0529-0005
Agency: epa
Document Type: Rule
Title: Exemption from the Requirement of a Tolerance: Laminarin
Posted Date: 2010-02-24T05:00Z

[Federal Register: February 24, 2010 (Volume 75, Number 36)]
[Rules and Regulations]               
[Page 8252-8256]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24fe10-8]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0529; FRL-8812-1]

 
Laminarin; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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 Go[euml]mar 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 February 24, 2010. Objections and 
requests for hearings must be received on or before April 26, 2010, 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-2008-0529. 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.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.

[[Page 8253]]

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-2008-0529 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 April 26, 2010.
    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-2008-0529, 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 Go[euml]mar 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. This notice 
included a summary of the petition prepared by the petitioner 
Laboratoires Go[euml]mar SA c/o SciReg, Inc. 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.
    Laminarin, a naturally occurring [beta]-glucan (polysaccharide 
carbohydrate), may be extracted from many types of brown algae (e.g., 
Laminaria digitata). Generally, [beta]-glucans are major constituents 
in the bran of most cereal grains and are intentionally added to many 
dietary supplements and texturing agents; therefore, these 
carbohydrates are typically consumed as a regular part of the human 
diet. Laminarin, specifically, is an integral part of the human diet in 
countries such as Ireland, France, and Japan, where Laminaria digitata 
is used for sea-vegetable production. As a biochemical active 
ingredient, laminarin stimulates the natural defense reactions of 
agricultural crops such as fruiting vegetables, tomato, eggplant, 
pepper, zucchini, cucurbits, watermelon, melons, grape, apple, pear, 
and strawberries against particular disease organisms (e.g., gray mold, 
powdery mildew, downy mildew, fire blight, and bacterial spot). As a 
naturally occurring oligosaccharide (a carbohydrate), residues of the 
active ingredient are indistinguishable from other naturally occurring 
plant oligosaccharides. In addition to the extensive history of 
consumption of [beta]-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

[[Page 8254]]

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 (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

[[Page 8255]]

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.

[[Page 8256]]

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.
    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).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(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 pests, Reporting and 
recordkeeping requirements.

    Dated: February 15, 2010.
Steven Bradbury,
Acting Director, Office of Pesticide Programs.

0
Therefore, 40 CFR part 180 is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.1295 is added to subpart D to read as follows:

Sec.  180.1295  Laminarin; exemption from the requirement of a 
tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of laminarin in or on all food commodities when laminarin is 
applied preharvest.

[FR Doc. 2010-3672 Filed 2-23-10; 8:45 am]
BILLING CODE 6560-50-S