71556 Federal Register / Vol. 75, No. 226 / Wednesday, November 24, 2010 / Rules and Regulations 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: November 16, 2010. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ 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. In § 180.910, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.910 Inert ingredients used pre-and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

N,N,N′,N′′,-tetrakis-(2-hydroxypropyl) ethylenediamine 

(102–60–3).

Concentration in formulated end-use products not to 

exceed 20% by weight in pesticide formulations.

Stabilizer for formulation. 

*******

■ 3. In § 180.930, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

N,N,N′,N′′,-tetrakis-(2-hydroxypropyl) ethylenediamine 

(102–60–3).

Concentration in formulated end-use products not to 

exceed 20% by weight in pesticide formulations.

Stabilizer for formulation. 

*******

[FR Doc. 2010–29647 Filed 11–23–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0061; FRL–8852–2] 

Polyoxyalkylated Glycerol Fatty Acid 

Esters; Tolerance Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of 

polyoxyalkylated glycerol fatty acid 

esters; the mono-, di-, or triglyceride 

mixtures of C8 through C22, primarily C8

through C18 saturated and unsaturated, 

fatty acids containing up to 15% water 

by weight reacted with a minimum of 

three moles of either ethylene oxide or 

propylene oxide, also known as 

polyoxyalkylated glycerol fatty acid 

esters, when used as an inert ingredient 

in a pesticide chemical formulation 

under 40 CFR 180.960. Croda Inc., 315 

Cherry Lane, Wilmington, DE 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 polyoxyalkylated 

glycerol fatty acid esters; the mono-, 

di-, or triglyceride mixtures of C8

through C22, primarily C8 through C18

saturated and unsaturated, fatty acids 

containing up to 15% water by weight 

reacted with a minimum of three moles 

of either ethylene oxide or propylene 

oxide, also known as polyoxyalkylated 

glycerol fatty acid esters, when used as 

an inert ingredient in a pesticide 

chemical formulation on food or feed 

commodities. 

DATES: This regulation is effective 

November 24, 2010. Objections and 

requests for hearings must be received 

on or before January 24, 2011, 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–2009–0661. 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: 

Kerry Leifer, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8811; e-mail address: 

leifer.kerry@epa.gov. 

SUPPLEMENTARY INFORMATION: 


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Federal Register / Vol. 75, No. 226 / Wednesday, November 24, 2010 / Rules and Regulations 71557 

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 FFDCA section 408(g), 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. 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–2009–0661 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before January 24, 2011. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

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. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2009–0661, 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 June 8, 2010 

(75 FR 32463) (FRL–8827–5), EPA 

issued a notice pursuant to section 408 

of FFDCA, 21 U.S.C. 346a, announcing 

the receipt of a pesticide petition (PP 

9E7538) filed by Croda Inc., 315 Cherry 

Lane, Wilmington, DE. The petition 

requested that 40 CFR 180.960 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of polyoxyalkylated glycerol 

fatty acid esters; the mono-, di-, or 

triglyceride mixtures of C8 through C22, 

primarily C8 through C18 saturated and 

unsaturated, fatty acids containing up to 

15% water by weight reacted with a 

minimum of three moles of either 

ethylene oxide or propylene oxide (CAS 

Reg. Nos. 61791–23–9, 68201–46–7, 

68440–49–3, 68458–88–8, 68606–12–2, 

68648–38–4, 70377–91–2, 70914–02–2, 

72245–12–6, 72698–41–3, 180254–52–8, 

248273–72–5, 308063–50–5, 952722– 

33–7). That notice included a summary 

of the petition prepared by the 

petitioner and solicited comments on 

the petitioner’s request. The Agency did 

not receive any comments. 

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 

use in residential settings, but does not 

include occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing an 

exemption from the requirement of 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 * * *’’ and specifies 

factors EPA is to consider in 

establishing an exemption. 

III. Risk Assessment and Statutory 

Findings 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be shown that the 

risks from aggregate exposure to 

pesticide chemical residues under 

reasonably foreseeable circumstances 

will pose no appreciable risks to human 

health. In order to determine the risks 

from aggregate exposure to pesticide 

inert ingredients, the Agency considers 

the toxicity of the inert in conjunction 

with possible exposure to residues of 

the inert ingredient through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. If 

EPA is able to determine that a finite 

tolerance is not necessary to ensure that 

there is a reasonable certainty that no 

harm will result from aggregate 

exposure to the inert ingredient, an 

exemption from the requirement of a 

tolerance may be established. 

Consistent with FFDCA section 

408(b)(2)(D), 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. In the 

case of certain chemical substances that 

are defined as polymers, the Agency has 

established a set of criteria to identify 

categories of polymers expected to 

present minimal or no risk. The 

definition of a polymer is given in 40 

CFR 723.250(b) and the exclusion 

criteria for identifying these low-risk 

polymers are described in 40 CFR 

723.250(d). Short chemical name 

conforms to the definition of a polymer 

given in 40 CFR 723.250(b) and meets 

the following criteria that are used to 

identify low-risk polymers. 


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71558 Federal Register / Vol. 75, No. 226 / Wednesday, November 24, 2010 / Rules and Regulations 

1. The polymer is not a cationic 

polymer nor is it reasonably anticipated 

to become a cationic polymer in a 

natural aquatic environment. 

2. The polymer does contain as an 

integral part of its composition the 

atomic elements carbon, hydrogen, and 

oxygen. 

3. The polymer does not contain as an 

integral part of its composition, except 

as impurities, any element other than 

those listed in 40 CFR 723.250(d)(2)(ii). 

4. The polymer is neither designed 

nor can it be reasonably anticipated to 

substantially degrade, decompose, or 

depolymerize. 

5. The polymer is manufactured or 

imported from monomers and/or 

reactants that are already included on 

the TSCA Chemical Substance 

Inventory or manufactured under an 

applicable TSCA section 5 exemption. 

6. The polymer is not a water 

absorbing polymer with a number 

average molecular weight (MW) greater 

than or equal to 10,000 daltons. 

Additionally, the polymer also meets 

as required the following exemption 

criteria specified in 40 CFR 723.250(e). 

7. The polymer’s number average MW 

of 1,500 is greater than 1,000 and less 

than 10,000 daltons. The polymer 

contains less than 10% oligomeric 

material below MW 500 and less than 

25% oligomeric material below 

MW1,000, and the polymer does not 

contain any reactive functional groups. 

Thus, polyoxyalkylated glycerol fatty 

acid esters meet the criteria for a 

polymer to be considered low risk under 

40 CFR 723.250. Based on its 

conformance to the criteria in this unit, 

no mammalian toxicity is anticipated 

from dietary, inhalation, or dermal 

exposure to polyoxyalkylated glycerol 

fatty acid esters. 

IV. Aggregate Exposures 

For the purposes of assessing 

potential exposure under this 

exemption, EPA considered that short 

chemical name could be present in all 

raw and processed agricultural 

commodities and drinking water, and 

that non-occupational non-dietary 

exposure was possible. The number 

average MW of polyoxyalkylated 

glycerol fatty acid esters is 1,500 

daltons. Generally, a polymer of this 

size would be poorly absorbed through 

the intact gastrointestinal tract or 

through intact human skin. Since 

polyoxyalkylated glycerol fatty acid 

esters conform to the criteria that 

identify a low-risk polymer, there are no 

concerns for risks associated with any 

potential exposure scenarios that are 

reasonably foreseeable. The Agency has 

determined that a tolerance is not 

necessary to protect the public health. 

V. Cumulative Effects From Substances 

With a Common Mechanism of Toxicity 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency considers 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found polyoxyalkylated 

glycerol fatty acid esters to share a 

common mechanism of toxicity with 

any other substances, and short 

chemical name does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that polyoxyalkylated glycerol 

fatty acid esters does not have a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www.epa.gov/pesticides/ 

cumulative. 

VI. Additional Safety Factor for the 

Protection of Infants and Children 

Section 408(b)(2)(C) of FFDCA 

provides that EPA shall apply an 

additional tenfold margin of safety for 

infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the data base unless 

EPA concludes that a different margin of 

safety will be safe for infants and 

children. Due to the expected low 

toxicity of polyoxyalkylated glycerol 

fatty acid esters, EPA has not used a 

safety factor analysis to assess the risk. 

For the same reasons the additional 

tenfold safety factor is unnecessary. 

VII. Determination of Safety 

Based on the conformance to the 

criteria used to identify a low-risk 

polymer, EPA concludes that there is a 

reasonable certainty of no harm to the 

U.S. population, including infants and 

children, from aggregate exposure to 

residues of polyoxyalkylated glycerol 

fatty acid esters. 

VIII. Other Considerations 

A. Existing Exemptions From a 

Tolerance 

There are no existing exemptions 

from the requirement of a tolerance for 

polyoxyalkylated glycerol fatty acid 

esters. 

B. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

C. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for polyoxyalkylated glycerol fatty acid 

esters. 

IX. Conclusion 

Accordingly, EPA finds that 

exempting residues of polyoxyalkylated 

glycerol fatty acid esters from the 

requirement of a tolerance will be safe. 

X. 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 rules 

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 involve any technical 

standards that would require Agency 

consideration of voluntary consensus 

standards pursuant to section 12(d) of 


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Federal Register / Vol. 75, No. 226 / Wednesday, November 24, 2010 / Rules and Regulations 71559 

the National Technology Transfer and 

Advancement Act of 1995 (NTTAA), 

Public Law 104–113, section 12(d) (15 

U.S.C. 272 note). 

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, or otherwise have any unique 

impacts on local governments. 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) (Pub. L. 

104–4). 

Although this action does not 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), EPA seeks to 

achieve environmental justice, the fair 

treatment and meaningful involvement 

of any group, including minority and/or 

low-income populations, in the 

development, implementation, and 

enforcement of environmental laws, 

regulations, and policies. As such, to the 

extent that information is publicly 

available or was submitted in comments 

to EPA, the Agency considered whether 

groups or segments of the population, as 

a result of their location, cultural 

practices, or other factors, may have 

atypical or disproportionately high and 

adverse human health impacts or 

environmental effects from exposure to 

the pesticide discussed in this 

document, compared to the general 

population. 

XI. 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 rule in the Federal 

Register. This 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: November 17, 2010. 

G. Jeffery Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ 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. In § 180.960, the table is amended 

by adding alphabetically the following 

polymers to read as follows: 

§ 180.960 Polymers; exemptions from the 

requirement of a tolerance. 

* * * * * 

Polymer CAS No. 

******

Polyoxyalkylated glycerol fatty acid esters; the mono-, 

di-, or triglyceride mixtures of C8 through C22, primarily C8 through C18 saturated 

and unsaturated, fatty acids containing up to 15% water by weight reacted with a 

minimum of three moles of either ethylene oxide or propylene oxide; the resulting 

polyoxyalkylated glycerol ester polymer minimum number average molecular weight 

(in amu), 1,500.

61791–23–9, 68201–46–7, 68440–49–3, 68458–88–8, 

68606–12–2, 68648–38–4, 70377–91–2, 70914–02–2, 

72245–12–6, 72698–41–3, 180254–52–8, 248273– 

72–5, 308063–50–5, 952722–33–7. 

* * * * * * * 

[FR Doc. 2010–29625 Filed 11–23–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 261 

[EPA–R06–RCRA–2010–0066; SW FRL– 

9231–4] 

Hazardous Waste Management 

System; Identification and Listing of 

Hazardous Waste; Withdrawal of Direct 

Final Exclusion 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Withdrawal of direct final 

exclusion. 

SUMMARY: Because EPA received 

adverse comments, we are withdrawing 

the direct final exclusion for 

ExxonMobil Refining and Supply 

Company—Beaumont Refinery, 

published on October 1, 2010. 

DATES: Effective November 24, 2010, 

EPA withdraws the direct final 

exclusion published at 75 FR 60632, on 

October 1, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Michelle Peace, Environmental 

Protection Agency, Multimedia 

Planning and Permitting Division, 

RCRA Branch, Mail Code: 6PD–C, 1445 

Ross Avenue, Dallas, TX 75202, by 


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