Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations 78143 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action 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: December 3, 2015. 

Robert McNally, 

Director, Biopesticides and Pollution 

Prevention 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. Revise § 180.1128 to read as 

follows: 

§ 180.1128 Bacillus amyloliquefaciens 

MBI600; exemption from the requirement of 

a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of the biofungicide Bacillus 

amyloliquefaciens MBI600 (antecedent 

Bacillus subtilis MBI600) in or on all 

food commodities, including residues 

resulting from post-harvest uses, when 

applied or used in accordance with 

good agricultural practices. 

[FR Doc. 2015–31462 Filed 12–15–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0766; FRL–9939–95] 

Extension of Pesticide Residue 

Tolerances for Emergency Exemptions 

(Multiple Chemicals) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation extends 

existing time-limited tolerances for 

residues of the pesticides bifenthrin in 

or on apple, peach and nectarine; 

dinotefuran in or on pome fruit and 

stone fruit; imidacloprid in or on 

sugarcane, cane and sugarcane 

molasses; and streptomycin in or on 

grapefruit and grapefruit, dried pulp. 

These actions are in response to EPA’s 

granting of emergency exemptions 

under the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) 

authorizing use of these pesticides. In 

addition, the Federal Food, Drug, and 

Cosmetic Act (FFDCA) requires EPA to 

establish a time-limited tolerance or 

exemption from the requirement for a 

tolerance for pesticide chemical 

residues in food that will result from the 

use of a pesticide under an emergency 

exemption granted by EPA. 

DATES: This regulation is effective 

December 16, 2015. Objections and 

requests for hearings must be received 

on or before February 16, 2016, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2015–0766, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

C. How 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–2015–0766 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

received by the Hearing Clerk on or 

before February 16, 2016. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2015–0766 by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave., 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http://

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

http://www.epa.gov/dockets. 


tkelley on DSK3SPTVN1PROD with RULES
78144 Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations 

II. Background and Statutory Findings 

EPA published final rules in the 

Federal Register for each chemical 

listed. The initial issuance of these final 

rules announced that EPA, on its own 

initiative, under FFDCA section 408, 21 

U.S.C. 346a, was establishing timelimited tolerances for residues of a 

pesticide in or on one or more food 

commodities. 

EPA established the tolerances 

because FFDCA section 408(l)(6) 

requires EPA to establish a time-limited 

tolerance, or exemption from the 

requirement for a tolerance, for 

pesticide chemical residues in food that 

will result from the use of a pesticide 

under an emergency exemption granted 

by EPA under FIFRA section 18. Such 

tolerances can be established without 

providing notice or time for public 

comment. 

EPA received requests to extend the 

emergency use of these chemicals for 

this year’s growing season. After having 

reviewed these submissions, EPA 

concurs that emergency conditions 

continue to exist. EPA assessed the 

potential risks presented by residues for 

each chemical. In doing so, EPA 

considered the safety standard in 

FFDCA section 408(b)(2), and decided 

that the necessary tolerance under 

FFDCA section 408(l)(6) would be 

consistent with the safety standard and 

with FIFRA section 18. 

The data and other relevant material 

have been evaluated and discussed in 

the final rules originally published to 

support these uses. Based on that data 

and information considered, the Agency 

reaffirms that extension of these timelimited tolerances will continue to meet 

the requirements of FFDCA section 

408(l)(6). Therefore, each of the timelimited tolerances is extended until the 

date listed, when they will expire and 

become revoked. EPA intends to publish 

a document in the Federal Register to 

remove the revoked tolerances from the 

Code of Federal Regulations (CFR). 

Although these tolerances will expire 

and are revoked on the dates listed, 

under FFDCA section 408(l)(5), residues 

of a pesticide not in excess of the 

amount specified in the tolerance 

remaining in or on a commodity after 

that date will not be unlawful, provided 

the residues are present as a result of an 

application or use of the pesticide at a 

time and in a manner that was lawful 

under FIFRA, a tolerance was in place 

at the time of the application, and the 

residues do not exceed the level that 

was authorized by the tolerance. EPA 

will take action to revoke these 

tolerances earlier if any experience 

with, scientific data on, or other 

relevant information on these pesticides 

indicates that the residues are not safe. 

Tolerances for the use of the following 

pesticide chemicals on specific 

commodities are being extended: 

Bifenthrin. EPA has authorized under 

FIFRA section 18 the use of bifenthrin 

on apple, peach, and nectarine for 

control of the brown marmorated 

stinkbug in multiple states. This 

regulation extends existing time-limited 

tolerances for residues of the insecticide 

bifenthrin, including its metabolites and 

degradates, in or on apple, peach, and 

nectarine at 0.5 part per million (ppm) 

for an additional 3-year period. These 

tolerances will expire and are revoked 

on December 31, 2018. The time-limited 

tolerances were originally published in 

the Federal Register of September 14, 

2012 (77 FR 56782) (FRL–9361–6). 

Dinotefuran. EPA has authorized 

under FIFRA section 18 the use of 

dinotefuran on pome fruit and stone 

fruit for control of the brown 

marmorated stinkbug in multiple states. 

This regulation extends existing timelimited tolerances for residues of the 

insecticide dinotefuran, including its 

metabolites and degradates, in or on 

fruit, pome, group 11 and fruit, stone, 

group 12 at 2.0 ppm for an additional 

three-year period. These tolerances will 

expire and are revoked on December 31, 

2018. The time-limited tolerances were 

originally published in the Federal 

Register of November 9, 2012 (77 FR 

67282) (FRL–9366–3), and revised in the 

Federal Register of January 22, 2014 (79 

FR 3508) (FRL–9402–8). 

Imidacloprid. EPA has authorized 

under FIFRA section 18 the use of 

imidacloprid on sugarcane for control of 

the West Indian cane fly in Louisiana. 

This regulation extends existing timelimited tolerances for residues of the 

insecticide imidacloprid, including its 

metabolites and degradates, in or on 

sugarcane, cane at 6.0 ppm and 

sugarcane, molasses at 50 ppm for an 

additional 3-year period. These 

tolerances will expire and are revoked 

on December 31, 2018. The time-limited 

tolerances were originally published in 

the Federal Register of June 5, 2013 (78 

FR 33736) (FRL–9387–9). 

Streptomycin. EPA has authorized 

under FIFRA section 18 the use of 

streptomycin on grapefruit for control of 

citrus canker in Florida. This regulation 

extends existing time-limited tolerances 

for residues of the pesticide 

streptomycin, including its metabolites 

and degradates, in or on grapefruit at 

0.15 ppm and grapefruit, dried pulp at 

0.40 ppm for an additional 3-year 

period. These tolerances will expire and 

are revoked on December 31, 2018. The 

time-limited tolerances were originally 

published in the Federal Register of 

May 17, 2013 (78 FR 29049) (FRL–9385– 

3). 

III. 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 

United Nations 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 MRLs 

for bifenthrin in/on apple, peach, or 

nectarine; dinotefuran in/on pome fruit 

or stone fruit; imidacloprid in/on 

sugarcane, cane or sugarcane molasses; 

nor streptomycin in/on grapefruit or 

grapefruit, dried pulp. 

IV. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA sections 408(e) and 

408(l)(6). 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 action 

has been exempted from review under 

Executive Order 12866, this action 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 action 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). 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations 78145 

Since tolerances and exemptions that 

are established under FFDCA sections 

408(e) and 408(l)(6), such as the 

tolerances 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 action 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 FFDCA 

section 408(n)(4). 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 action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

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 

(NTTAA) (15 U.S.C. 272 note). 

V. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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: December 8, 2015. 

Daniel J. Rosenblatt, 

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 § 180.245, revise the table in 

paragraph (b) to read as follows: 

§ 180.245 Streptomycin; tolerances for 

residues. 

* * * * * 

(b) * * * 

Commodity Parts per million Expiration/ 

revocation date 

Grapefruit ......................................................................................................................................................... 0.15 12/31/2018 

Grapefruit, dried pulp ....................................................................................................................................... 0.40 12/31/2018 

* * * * * 

■ 3. In § 180.442, revise the table in 

paragraph (b) to read as follows: 

§ 180.442 Bifenthrin; tolerances for 

residues. 

* * * * * 

(b) * * * 

Commodity Parts per million Expiration/ 

revocation date 

Apple ................................................................................................................................................................ 0.5 12/31/2018 

Nectarine .......................................................................................................................................................... 0.5 12/31/2018 

Peach ............................................................................................................................................................... 0.5 12/31/2018 

* * * * * 

■ 4. In § 180.472, revise the table in 

paragraph (b) to read as follows: 

§ 180.472 Imidacloprid; tolerances for 

residues. 

* * * * * 

(b) * * * 

Commodity Parts per million Expiration/ 

revocation date 

Sugarcane, cane .............................................................................................................................................. 6.0 12/31/2018 

Sugarcane, molasses ...................................................................................................................................... 50 12/31/2018 

* * * * * 

■ 5. In § 180.603, revise the table in 

paragraph (b) to read as follows: 

§ 180.603 Dinotefuran; tolerances for 

residues. 

* * * * * 

(b) * * * 

Commodity Parts per million Expiration/ 

revocation date 

Fruit, pome, Group 11 ..................................................................................................................................... 2.0 12/31/2018 

Fruit, stone, Group 12 ..................................................................................................................................... 2.0 12/31/2018 


tkelley on DSK3SPTVN1PROD with RULES
78146 Federal Register / Vol. 80, No. 241 / Wednesday, December 16, 2015 / Rules and Regulations 

* * * * * 

[FR Doc. 2015–31518 Filed 12–15–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0023; FRL–9935–81] 

Choline Chloride; 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 the Choline 

Chloride (Acetyl Choline) in or on all 

food commodities when applied/used 

pre-harvest and used in accordance with 

label directions and good agricultural 

practices. CP Bio, 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 Choline Chloride. 

DATES: This regulation is effective 

December 16, 2015. Objections and 

requests for hearings must be received 

on or before February 16, 2016, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2015–0023, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Robert McNally, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

BPPDFRNotices@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How 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–2015–0023 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 February 16, 2016. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2015–0023, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.html. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

available at http://www.epa.gov/ 

dockets. 

II. Background and Statutory Findings 

In the Federal Register of March 4, 

2015 (80 FR 11611) (FRL–9922–68), 

EPA issued a document pursuant to 

FFDCA section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide tolerance petition (PP 4F8287) 

by CP Bio, Inc., 4802 Murrieta Street, 

Chino, CA 91710. The petition 

requested that 40 CFR part 180 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of Choline Chloride in or on all 

food commodities (when applied preharvest). That document referenced a 

summary of the petition prepared by the 

petitioner CP Bio, Inc., which is 

available in the docket, http:// 

www.regulations.gov. There were no 

substantive 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 

FFDCA section 408(c)(2)(B), in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in FFDCA section 

408(b)(2)(C), which require EPA to give 

special consideration to exposure of 


tkelley on DSK3SPTVN1PROD with RULES