Federal Register / Vol. 77, No. 50 / Wednesday, March 14, 2012 / Proposed Rules 15015 

Antimicrobials Division (7510P), (703) 

308–8075, email address: 

luminello.tom@epa.gov. 

4. PP 1F7917. (EPA–HQ–OPP–2011– 

1026). Bert Volger, Ceres International 

LLC., 1087 Heartsease Drive, West 

Chester, PA 19382 (on behalf of 

Consumo Em Verde S.A., Biotecnologia 

De Plantas, Parque Tecnolo ́gico de 

Cantanhede, Nu ́ cleo 04, Lote 2, 3060– 

197 Cantanhede, Portugal), requests to 

establish an exemption from the 

requirement of tolerances for residues of 

the biofungicide BLAD, a naturally 

occurring polypeptide from the 

catabolism of a seed storage protein of 

sweet lupines (Lupinus albus), in or on 

various crops and ornamentals. The 

petitioner believes no analytical method 

is needed because the requirements of 

an analytical method are not applicable 

to a request to establish an exemption 

from the requirement of a tolerance. 

Contact: Menyon Adams, Biopesticides 

and Pollution Prevention Division 

(7511P), (703) 347–8496, email address: 

adams.menyon@epa.gov. 

5. PP 9F7670. (EPA–HQ–OPP–2010– 

0065). Technology Sciences Group, Inc., 

1150 18th Street, NW., Suite 1000, 

Washington, DC 20036, (on behalf of 

AMVAC Chemical Corporation, 4695 

MacArthur Court, Suite 1250, Newport 

Beach, CA 90660), requests to establish 

an exemption from the requirement of a 

tolerance for residues of the biochemical 

potato sprout inhibitor, 3-decen-2-one, 

as a post-harvest treatment, in or on 

stored potatoes. An analytical method 

for residues is not applicable. It is 

expected that, when used as proposed, 

3-decen-2-one would not result in 

residues that are of toxicological 

concern. The Agency is re-issuing this 

notice of filing (NOF) of a pesticide 

petition for 3-decen-2-one (PP 9F7670) 

because the petitioner revised the 

pending petition. Instead of proposing 

an exemption from the requirement of a 

tolerance for residues of the potato 

sprout inhibitor, 3-decen-2-one, in or on 

all food commodities, the petitioner is 

now requesting the tolerance exemption 

for use of 3-decen-2-one as a postharvest treatment on stored potatoes 

only. The original NOF published in the 

Federal Register for comment on March 

10, 2010 (75 FR 11171)(FRL–8810–8), 

with a 30 day comment period. One 

comment was received in response to 

this NOF. The Agency will respond to 

this comment in the final rule but notes 

that the comment was not germane to 

the active ingredient described herein, 

and focused on concerns that were not 

specific to dietary exposure. Contact: 

Colin G. Walsh, Biopesticides and 

Pollution Prevention Division (7511P), 

(703) 308–0298, email address: 

walsh.colin@epa.gov. 

Amended Tolerance Exemptions 

1. PP 1E7931. (EPA–HQ–OPP–2011– 

0949). BASF Corporation, 100 Campus 

Drive, Florham Park, NJ 07932, requests 

to amend an exemption from the 

requirement of a tolerance for residues 

of N,N-Bis-a-ethyl-w-hydroxypoly(oxy1,2-ethanediyl) C8-C18 saturated and 

unsaturated alkylamines; the poly(oxy1,2-ethanediyl) content is 2–60 moles; 

herein referred to as Alkyl Amines 

Polyalkoxylates under 40 CFR 180.920 

and 180.930 to include CAS No. 

1266162–49–5 when used as a pesticide 

inert ingredient in pesticide 

formulations. An analytical method is 

not required for enforcement purposes 

since the Agency has established an 

exemption from the requirement of a 

tolerance without any numerical 

limitation. Contact: Elizabeth Fertich, 

Registration Division (7505P), (703) 

347–8560, email address: 

fertich.elizabeth@epa.gov. 

2. PP 1F7914. (EPA–HQ–OPP–2011– 

1033). Albemarle Corporation, 451 

Florida Street, Baton Rouge, LA 70801, 

requests to amend 40 CFR 180.940(a) by 

establishing an exemption from the 

requirement of a tolerance for the 

residues of the antimicrobial 1,2- 

dibromo-5,5-dimethylhyadantoin (CAS 

Reg. No. 77–48–5) in antimicrobial 

formulations, in or on food contact 

surface sanitizing solutions. May be 

applied to: Food contact surfaces in 

public eating places, dairy processing 

equipment, and food-processing 

equipment and utensils. When ready for 

use, end-use concentration of all 

bromine-producing chemicals in 

solution is not to exceed 500 ppm of 

total bromine. Analytical method is not 

necessary since 1,3-dibromo-5,5- 

dimethylhydantoin residues are 

exempted from the requirements of a 

tolerance. Contact: Tom Luminello, 

Antimicrobials Division (7510P), (703) 

308–8075, email address: 

luminello.tom@epa.gov. 

3. PP 1F7920. (EPA–HQ–OPP–2011– 

1029). D–I–1–4, Inc., a Division of 1,4 

Group, Inc., P.O. Box 680, Meridian, ID 

83680, requests to amend an exemption 

from the requirement of a tolerance in 

40 CFR 180.1142 for residues of the 

plant growth regulator 1,4- 

Dimethylnaphthalene (1,4-DMN) when 

applied post-harvest to potatoes and 

other sprouting root, tuber and bulb 

crops in accordance with good 

agricultural practices. An analytical 

method for residues is not applicable. It 

is expected that, when used as 

proposed, 1,4-Dimethylnaphthalene 

would not result in residues that are of 

toxicological concern. Contact: Colin G. 

Walsh, Biopesticides and Pollution 

Prevention Division (7511P), (703) 308– 

0298, email address: 

walsh.colin@epa.gov. 

4. PP 1F7940. (EPA–HQ–OPP–2011– 

1028). Kaken Pharmaceutical Co., Ltd., 

c/o Conn & Smith, Inc., Agent, 6713 

Catskill Road, Lorton, VA 22079, 

requests to amend an existing 

exemption from the requirement of 

tolerances in 40 CFR 180.1285 for 

residues of the biochemical pesticide 

polyoxin D zinc salt when used as a 

fungicide for pre-harvest and postharvest uses in accordance with good 

agricultural practices, in or on all 

agricultural commodities. A tolerance 

exemption is proposed. Therefore, no 

tolerance enforcement method is 

proposed. Contact: Colin G. Walsh, 

Biopesticides and Pollution Prevention 

Division (7511P), (703) 308–0298, email 

address: walsh.colin@epa.gov. 

List of Subjects 

Environmental protection, 

Agricultural commodities, Feed 

additives, Food additives, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 28, 2012. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

[FR Doc. 2012–6056 Filed 3–13–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0964; FRL–9332–3] 

Revocation of Tolerance Exemptions 

for Diethyl Phthalate and Methyl Ethyl 

Ketone; No Data Being Developed as 

Required by Test Orders (Data Call-Ins) 

Under EPA’s Endocrine Disruptor 

Screening Program 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: This document proposes, 

under section 408(e)(1) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

to revoke the existing exemptions from 

the requirement of a tolerance (tolerance 

exemptions) for residues of diethyl 

phthalate and methyl ethyl ketone when 

used as inert ingredients in pesticide 

products because there are insufficient 

data to make the determination of safety 

required by FFDCA. No manufacturer or 

importer of these chemicals has 

committed to conduct testing and 


pstrozier on DSK7SPTVN1PROD with PROPOSALS
15016 Federal Register / Vol. 77, No. 50 / Wednesday, March 14, 2012 / Proposed Rules 

submit data required by test orders that 

EPA issued under the Endocrine 

Disruptor Screening Program (EDSP). 

EPA is, however, offering an 

opportunity for interested parties to 

comment or commit to submitting the 

required data. 

DATES: Comments must be received on 

or before May 14, 2012. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–0964, 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. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPP–2011– 

0964. EPA’s policy is that all comments 

received will be included in the docket 

without change and may be made 

available on-line at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or 

email. The regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an email comment directly 

to EPA without going through 

regulations.gov, your email address will 

be automatically captured and included 

as part of the comment that is placed in 

the docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: 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., 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 either 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 

hours of operation of this Docket 

Facility are 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: 

Anthony Britten, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8179; fax number: (703) 605– 

0781; email address: 

britten.anthony@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; or if you 

manufacture or import chemical 

substances that are used in pesticides. 

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). 

• Chemical manufacturers, importers 

and processors (NAICS code 325). 

• Pesticide, fertilizer, and other 

agricultural chemical manufacturing 

(NAICS code 3253). 

• Scientific research and 

development services (NAICS code 

5417) e.g., persons who conduct testing 

of chemical substances for endocrine 

effects. 

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. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 


pstrozier on DSK7SPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 50 / Wednesday, March 14, 2012 / Proposed Rules 15017 

C. What can I do if I wish EPA to 

maintain a tolerance or tolerance 

exemption that the agency proposes to 

revoke? 

This proposed rule provides a 

comment period of 60 days for any 

person to state an interest in retaining 

a tolerance exemption proposed for 

revocation. If EPA receives a comment 

within the 60-day period to that effect, 

EPA will not proceed to revoke the 

tolerance exemption immediately. 

However, EPA will take steps to ensure 

the submission of any needed 

supporting data and will either issue an 

order under sections 3(c)(2)(B) of the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) and section 

408(p)(5) of FFDCA if the commenter is 

a registrant or manufacturer, or will 

issue an order in the Federal Register 

under FFDCA section 408(f) if the 

interested party is neither a registrant 

nor manufacturer. 

EPA issues a final rule after 

considering comments that are 

submitted in response to this proposed 

rule. Comments should be limited only 

to the inert ingredients and tolerance 

exemptions subject to this proposed 

rule. After considering comments, EPA 

will issue a final regulation determining 

whether revocation of the tolerance 

exemptions is appropriate and making a 

final finding on whether these tolerance 

exemptions are ‘‘safe’’ within the 

meaning of section 408(b)(2)(A)(ii). 

In addition to submitting comments 

in response to this proposal, you may 

also submit an objection at the time of 

the final rule pursuant to section 408(g) 

(21 U.S.C. 346a(g)). If you anticipate that 

you may wish to file objections to the 

final rule, you must raise those issues in 

your comments on this proposal. EPA 

will treat as waived any issues raised in 

objections that could reasonably have 

been, but were not, presented in 

comments on this proposal. Similarly, if 

you fail to file an objection to the final 

rule within the time period specified, 

you will have waived the right to raise 

any issues resolved in the final rule. 

After the specified time, issues resolved 

in the final rule cannot be raised again 

in any subsequent proceedings. 

II. Background 

A. What action is the agency taking? 

EPA, under section 408(e)(1) of 

FFDCA, is proposing to revoke tolerance 

exemptions for residues of diethyl 

phthalate and methyl ethyl ketone in or 

on raw agricultural commodities and 

processed foods when these chemicals 

are used as inert ingredients in pesticide 

products. These revocations would be 

effective 6 months after the final rule is 

published in the Federal Register. 

EPA issued test orders to 

manufacturers and importers of diethyl 

phthalate and methyl ethyl ketone on 

January 21, 2010 and January 28, 2010, 

respectively. The test orders required 

recipients to generate data that would 

allow the Agency to screen these 

chemicals for their potential to interact 

with the estrogen, androgen or thyroid 

hormonal systems consistent with EPA’s 

Endocrine Disruptor Screening Program 

(EDSP), developed in accordance with 

section 408(p) of FFDCA. 

Section 408(p)(3) of FFDCA requires 

screening of ‘‘all pesticide chemicals,’’ 

including by definition inert ingredients 

in pesticide products, to determine their 

potential to disrupt the endocrine 

system. 21 U.S.C. 345a(p)(3). The statute 

also ties the availability of these or other 

data ‘‘on whether the pesticide chemical 

may have an effect in humans that is 

similar to an effect produced by a 

naturally occurring estrogen or other 

endocrine effects’’ to the safety finding 

that EPA must make in order to allow 

a tolerance or exemption to remain. 21 

U.S.C. 346a(b)(2)(D). 

No company which received a test 

order has committed to submit the 

required data to support the continued 

use of these chemicals as pesticide inert 

ingredients. Rather, all elected to ‘‘opt 

out’’ of the pesticide market rather than 

conduct testing, and under the ‘‘optout’’ provision, were required to cease, 

within 6 months of EPA issuing the test 

order, all sales and distribution of their 

chemical for use in pesticide 

formulations. 

EPA’s outreach to trade associations 

suggests that registrants of pesticide 

products will also decline to conduct 

required testing in order to continue 

using these chemicals as inert 

ingredients. EPA therefore is not issuing 

further test orders at this time. Rather, 

this proposed rule offers a final 

opportunity for any interested parties to 

commit to develop these data, which 

FFDCA makes necessary to support a 

tolerance or exemption. A companion 

notice in this issue of the Federal 

Register provides background on all the 

inert ingredient test orders issued and 

the responses EPA has received to date. 

In sum, because no one has 

committed to generate these data, and 

because EPA has no other data on which 

it could rely to evaluate the endocrine 

disruption potential of these inert 

ingredients, EPA is proposing to revoke 

the tolerance exemption under 40 CFR 

180.930 for diethyl phthalate and the 

tolerance exemption under 40 CFR 

180.920 for methyl ethyl ketone. In the 

absence of any data bearing on the 

endocrine disruption potential of these 

chemicals, EPA cannot find that these 

chemicals continue to meet the required 

safety standard under FFDCA section 

408(b)(2). Through this proposed rule, 

the Agency is inviting individuals who 

need these exemptions to identify 

themselves and the tolerance 

exemptions that are needed. If during 

the comment period for this proposal no 

one either submits or commits to 

generate data required by the test orders, 

EPA will revoke these tolerance 

exemptions. The following list identifies 

the data EPA required in the test orders 

to screen for potential effects on the 

thyroid, estrogen and androgen systems, 

and the estimated time to generate the 

data. If screening data were to identify 

endocrine activity, additional testing 

might be required to establish doselevels for adverse effects. 

Required Data and Estimated Number of 

Months to Develop 

Amphibian Metamorphosis (Frog): 15. 

Androgen Receptor Binding (Rat 

Prostate): 6. 

Aromatase (Human Recombinant): 6. 

Estrogen Receptor Binding: 6. 

Estrogen Receptor Transcriptional 

Activation (Human Cell Line (HeLa9903)): 6. 

Fish Short-term Reproduction: 12. 

Hershberger (Rat): 9. 

Female Pubertal (Rat): 15. 

Male Pubertal (Rat): 15. 

Steroidogenesis (Human Cell Line— 

H295R): 6. 

Uterotrophic (Rat): 9. 

EPA has loaded a sample test order in 

the docket for reference. If after reading 

this proposed rule and the test order 

requirements, you intend to submit 

data, indicate this clearly in your 

comments. 

B. What is the agency’s authority for 

taking this action? 

This proposed rule is issued pursuant 

to section 408(e)(1)(B) of FFDCA (21 

U.S.C. 346a(e)(1)(B)). A ‘‘tolerance’’ 

represents the maximum level for 

residues of pesticide chemicals legally 

allowed in or on raw agricultural 

commodities and processed foods. 

Section 408 of FFDCA, 21 U.S.C. 346a, 

as amended by the Food Quality 

Protection Act of 1996 (FQPA), Public 

Law 104–170, authorizes the 

establishment of tolerances, exemptions 

from tolerance requirements, 

modifications in tolerances, and 

revocation of tolerances for residues of 

pesticide chemicals in or on raw 

agricultural commodities and processed 

foods. Without a tolerance or 

exemption, food containing pesticide 

residues is considered to be unsafe and 


pstrozier on DSK7SPTVN1PROD with PROPOSALS
15018 Federal Register / Vol. 77, No. 50 / Wednesday, March 14, 2012 / Proposed Rules 

therefore ‘‘adulterated’’ under section 

402(a) of FFDCA, 21 U.S.C. 342(a). Such 

food may not be distributed in interstate 

commerce (21 U.S.C. 331(a)). 

Section 408(b)(2)(A)(i) of the FFDCA 

requires EPA to modify or revoke a 

tolerance if EPA determines that the 

tolerance is not ‘‘safe.’’ 21 U.S.C. 

346a(b)(2)(A)(ii). Section 408(b)(2)(A)(ii) 

of the 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.’’ Among those factors that 

EPA is directed to consider in 

establishing, modifying, leaving in 

effect, or revoking a tolerance or 

exemption for a pesticide chemical 

residue is ‘‘such information as the 

Administrator may require on whether 

the pesticide chemical may have an 

effect in humans that is similar to an 

effect produced by a naturally occurring 

estrogen or other endocrine effects; 

* * *.’’ 21 U.S.C. 346a(b)(2)(D)(viii). 

FFDCA section 408(p)(1) requires EPA 

‘‘to develop a screening program, using 

appropriate validated test systems and 

other scientifically relevant information 

to determine whether certain substances 

may have an effect in humans that is 

similar to an effect produced by a 

naturally occurring estrogen, or such 

other effects as [EPA] may designate.’’ 

21 U.S.C. 346a(p). FFDCA section 

408(p)(3) expressly requires that EPA 

‘‘shall provide for the testing of all 

pesticide chemicals.’’ FFDCA section 

201 defines ‘‘pesticide chemical’’ as 

‘‘any substance that is a pesticide within 

the meaning of the Federal Insecticide, 

Fungicide, and Rodenticide Act 

(FIFRA), including all active and 

pesticide inert ingredients of such 

pesticide.’’ 21 U.S.C. 231(q)(1). FFDCA 

section 408(e)(1)(B) provides that the 

Administrator may issue a regulation 

‘‘establishing, modifying, suspending 

under section (l)(3), or revoking an 

exemption of a pesticide chemical 

residue from the requirement of a 

tolerance.’’ 21 U.S.C. 346a(e)(1)(B). 

C. When would this action become 

effective? 

EPA is proposing to revoke the 

tolerance exemptions for diethyl 

phthalate and methyl ethyl ketone 

effective 6 months after the date the 

final rule publishes in the Federal 

Register. EPA believes its proposed 

timeline gives registrants sufficient time 

to take appropriate action. Under the 

EDSP test orders, manufacturers and 

importers that ‘‘opted out’’ of testing 

had to cease all sales and distribution of 

the chemical to the pesticide market for 

use in formulating pesticide products 

within 6 months of EPA issuing the test 

order. EPA issued the last test orders for 

these chemicals on January 28, 2010, so 

all sales and distribution of diethyl 

phthalate and methyl ethyl ketone for 

use in formulating pesticide products 

were to have ceased as of July 28, 2010. 

EPA has also been performing outreach 

to trade groups to inform them about the 

potential loss of these chemicals as inert 

ingredients. This Federal Register 

document provides further notice. 

Any commodities treated with 

pesticide products containing the inert 

ingredients diethyl phthalate and 

methyl ethyl ketone and in the channels 

of trade following the tolerance 

revocations, shall be subject to FFDCA 

section 408(1)(5), as established by 

FQPA. Under this section, any residues 

of these pesticide chemicals in or on 

such food shall not render the food 

adulterated so long as it is shown to the 

satisfaction of FDA that: 

i. The residue is present as the result 

of an application or use of the pesticide 

at a time and in a manner that was 

lawful under FIFRA. 

ii. The residue does not exceed the 

level that was authorized, at the time of 

the application or use, to be present on 

the food under a tolerance or exemption 

from a tolerance. Evidence to show that 

food was lawfully treated may include 

records that verify the dates when the 

pesticide was applied to such food. 

III. Statutory and Executive Order 

Reviews 

EPA is proposing to revoke the 

exemptions from the requirement of a 

tolerance for diethyl phthalate and 

methyl ethyl ketone. 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 proposed rule has been 

exempted from review under Executive 

Order 12866 due to its lack of 

significance, this proposed 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). This proposed rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., or 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). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

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). Since 

tolerances and exemptions that are 

established on the basis of a petition 

under section 408(d) of the FFDCA, 

such as the tolerance in this proposed 

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. The 

Agency hereby certifies that this 

proposed action will not have a 

significant negative economic impact on 

a substantial number of small entities. 

In addition, the Agency has determined 

that this action will not have a 

substantial direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This proposed 

rule directly regulates growers, food 

processors, food handlers, and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this 

proposed rule does not have any ‘‘tribal 

implications’’ as described in Executive 

Order 13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 


pstrozier on DSK7SPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 50 / Wednesday, March 14, 2012 / Proposed Rules 15019 

9, 2000). Executive Order 13175 

requires EPA to develop an accountable 

process to ensure ‘‘meaningful and 

timely input by tribal officials in the 

development of regulatory policies that 

have tribal implications.’’ ‘‘Policies that 

have tribal implications’’ is defined in 

the Executive order to include 

regulations that have ‘‘substantial direct 

effects on one or more Indian tribes, on 

the relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

proposed rule will not have substantial 

direct effects on tribal governments, on 

the relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this proposed rule. 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Endocrine 

disruptors, Pesticides and pests, 

Reporting and recordkeeping 

requirements. 

Dated: February 17, 2012. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, it is proposed that 40 CFR 

chapter I be amended as follows: 

PART 180—[AMENDED] 

1. The authority citation for 40 CFR 

part 180 continues to read as follows: 

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

§ 180.920 [Amended] 

2. In § 180.920, the table is amended 

by removing the entire entry for 

‘‘Methyl ethyl ketone.’’ 

§ 180.930 [Amended] 

3. In § 180.930, the table is amended 

by removing the entire entry for 

‘‘Diethylphthalate.’’ 

[FR Doc. 2012–6210 Filed 3–13–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Parts 13, 17, and 23 

[Docket No. FWS–R9–IA–2010–0083; 96300– 

1671–0000–R4] 

RIN 1018–AW82 

Revision of Regulations Implementing 

the Convention on International Trade 

in Endangered Species of Wild Fauna 

and Flora (CITES); Updates Following 

the Fifteenth Meeting of the 

Conference of the Parties to CITES; 

Correction 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Proposed rule; correction. 

SUMMARY: On March 8, 2012, we, the 

Fish and Wildlife Service (FWS or 

Service), published a proposed rule to 

revise the regulations that implement 

the Convention on International Trade 

in Endangered Species of Wild Fauna 

and Flora (CITES) by incorporating 

certain provisions adopted at the 

fourteenth and fifteenth meetings of the 

Conference of the Parties (CoP14 and 

CoP15) to CITES and clarifying and 

updating certain other provisions. 

Inadvertently, we made some errors in 

the DATES and ADDRESSES sections 

concerning the information collection 

aspects of the proposal. With this 

technical correction, we correct those 

errors. 

FOR FURTHER INFORMATION CONTACT: 

Robert R. Gabel, Chief, Division of 

Management Authority; U.S. Fish and 

Wildlife Service; 4401 N. Fairfax Drive, 

Suite 212; Arlington, VA 22203; 

telephone, 703–358–2093. 

SUPPLEMENTARY INFORMATION: On March 

8, 2012 (77 FR 14200), we published a 

proposed rule to revise the regulations 

that implement CITES. Inadvertently, 

we made some errors in the DATES and 

ADDRESSES sections concerning the 

information collection aspects of the 

proposal. With this technical correction, 

we correct those errors. 

Under DATES, we printed an incorrect 

date for the deadline for comments on 

the information collection aspects of the 

proposed rule. The correct date is April 

9, 2012. Comments on the information 

collection aspects of this proposed rule 

will be considered if received by April 

9, 2012. 

Under ADDRESSES, we printed an 

incorrect address to which to provide us 

a copy of your comments on the 

information collection aspects of the 

proposed rule. Please provide those 

comments to the Service Information 

Collection Clearance Officer, U.S. Fish 

and Wildlife Service, MS 2042–PDM, 

4401 N. Fairfax Drive, Arlington, VA 

22203. 

Dated: March 8, 2012. 

Sara Prigan, 

Federal Register Liaison. 

[FR Doc. 2012–6104 Filed 3–13–12; 8:45 am] 

BILLING CODE 4310–55–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 679 

RIN 0648–BB42 

Groundfish Fisheries of the Exclusive 

Economic Zone Off Alaska and Pacific 

Halibut Fisheries; Observer Program 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Notification of availability of 

fishery management plan amendment; 

request for comments. 

SUMMARY: The North Pacific Fishery 

Management Council submitted 

Amendment 86 to the Fishery 

Management Plan (FMP) for Groundfish 

of the Bering Sea and Aleutian Islands 

Management Area (BSAI) and 

Amendment 76 to the FMP for 

Groundfish of the Gulf of Alaska (GOA), 

(collectively referred to as the FMPs) to 

NMFS for review. If approved, 

Amendments 86 and 76 would add a 

funding and deployment system for 

observer coverage to the existing North 

Pacific Groundfish Observer Program 

(Observer Program) and amend existing 

observer coverage requirements for 

vessels and processing plants at 50 CFR 

679.50. The new funding and 

deployment system would allow NMFS 

to determine when and where to deploy 

observers according to management and 

conservation needs, with funds 

provided through a system of fees based 

on the ex-vessel value of groundfish and 

halibut in fisheries covered by the new 

system. This action is necessary to 

resolve data quality and cost equity 

concerns with the Observer Program’s 

existing funding and deployment 

structure. This action is intended to 

promote the goals and objectives of the 

Magnuson-Stevens Fishery 

Conservation and Management Act 

(MSA), the FMPs, and other applicable 

law. 


pstrozier on DSK7SPTVN1PROD with PROPOSALS