8252 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 

EPA-APPROVED VIRGINIA REGULATIONS AND STATUTES—Continued 

State citation Title/subject State effective 

date EPA approval date Explanation (former SIP citation) 

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Part I Special Provisions 

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5–40–20 ........... Compliance ...... 12/12/07 02/24/10 [Insert page number where the 

document begins].

Revisions to paragraph A.3. 

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9 VAC 5 Chapter 50 New and Modified Stationary Sources 

* * * * * * * 

Part I Special Provisions 

* * * * * * * 

5–50–20 ........... Compliance ...... 12/12/07 02/24/10 [Insert page number where the 

document begins].

Revisions to paragraph A.3. 

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[FR Doc. 2010–3512 Filed 2–23–10; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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 Goe ̈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. 


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Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 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 Goe ̈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 

Goe ̈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 bglucan (polysaccharide carbohydrate), 

may be extracted from many types of 

brown algae (e.g., Laminaria digitata). 

Generally, b-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 bglucans—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 


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8254 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 

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 treatmentrelated 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 nonoccupational 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 


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Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 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, SARinducing mode of action, and 

demonstrable lack of dietary effects. 

1. Dermal exposure. Nonoccupational 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. Nonoccupational 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 EPAapproved 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. 


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8256 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 

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. 

■ 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. 321(q), 346a and 371. 

■ 2. Section 180.1295 is added to 

subpart D to read as follows: 

§ 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

EPA–HQ–OPP–2009–0569; FRL–8812–5 

Nicosulfuron; Pesticide Tolerances for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

nicosulfuron, [3-pyridinecarboxamide, 

2-((((4,6-dimethoxypyrimidin-2-yl) 

aminocarbonyl) aminosulfonyl))-N,Ndimethyl]; in or on Bermudagrass, 

forage and Bermudagrass, hay. This 

action is in response to EPA granting 

crisis exemptions to the Texas 

Department of Agriculture and the 

Oklahoma Department of Agriculture 

under section 18 of the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA) authorizing use of the 

pesticide on Bermudagrass, forage and 

Bermudagrass, hay. This regulation 

establishes maximum permissible levels 

for residues of nicosulfuron in 

Bermudagrass and hay. The timelimited tolerances expire and are 

revoked on December 31, 2011. 

DATES: This regulation is effective 

February 24, 2010. Objections and 


cprice-sewell on DSK2BSOYB1PROD with RULES