Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Rules and Regulations 35295 

6. Loria R, Kers J, Joshi M. 2006. Evolution 

of plant pathology in Streptomyces. Annual 

Review of Phytopathology 44:469–487. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

exemption under section 408(d) of 

FFDCA in response to a petition 

submitted to EPA. 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 exemption 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. 

As a result, 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. As such, 

EPA 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, EPA 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). 

This action does not involve any 

technical standards that would require 

EPA 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). 

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 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: April 25, 2012. 

Steven Bradbury, 

Director, 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. Section 180.1314 is added to 

subpart D to read as follows: 

§ 180.1314 Killed, nonviable Streptomyces 

acidiscabies strain RL–110T; exemption 

from the requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of killed, nonviable Streptomyces 

acidiscabies strain RL–110T in or on all 

food commodities when applied as a 

pre- or post-emergent herbicide and 

used in accordance with good 

agricultural practices. 

[FR Doc. 2012–14243 Filed 6–12–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0245; FRL–9352–4] 

RIN 2070–ZA16 

Methyl Bromide; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of methyl bromide 

in or on cotton, undelinted seed under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA) because there is a need for 

imported undelinted cottonseed for use 

as additional feed for dairy cattle in the 

United States. 

DATES: This regulation is effective June 

13, 2012. Objections and requests for 

hearings must be received on or before 

August 13, 2012, 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–2012–0245; 

FRL–9352–4, is available either 

electronically through http:// 

www.regulations.gov or in hard copy at 

the OPP Docket in the Environmental 

Protection Agency Docket Center (EPA/ 

DC), located in EPA West, 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: 

Kimberly Nesci, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8059; email address: 

nesci.kimberly@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 


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35296 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Rules and Regulations 

not limited to those engaged in the 

following activities: 

• 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 to provide 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 EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://ecfr.gpoaccess.gov/cgi/t/ 

text/text-idx?&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–2012–0245 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 August 13, 2012. 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 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2012–0245, 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 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), Mail Code: 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.htm. 

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 

In the Federal Register of April 6, 

2012 (77 FR 20752) (FRL–9345–1), EPA 

issued a proposed rule pursuant to 

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

346a(d)(3). The rule proposed that 40 

CFR 180.124 be created to establish a 

tolerance for residues of methyl 

bromide, including metabolites and 

degradates in or on cotton, undelinted 

seed at 150 parts per million (ppm). 

EPA issued a proposed rule that 

explained the basis for EPA’s 

conclusion that there is a reasonable 

certainty that no harm will result to the 

general population, or to infants and 

children, from exposure to methyl 

bromide on cottonseed because there 

will be no human dietary exposure to 

methyl bromide from the use of methyl 

bromide to fumigate cottonseed. The 

proposal established a 60-day public 

comment period. Comments were 

received in response to the proposed 

rule. EPA’s response to these comments 

is discussed in Unit III. 

III. Response to Comments 

Comments were received in response 

to the proposed rule from a large dairy 

producer trade association, from a dairy 

industry expert, and from two other 

individuals. The comments from the 

dairy producer trade association and 

from the dairy industry expert are in 

support of the establishment of a 

tolerance for methyl bromide on 

cottonseed out of a concern with a 

shortage of domestically-grown 

cottonseed. These commenters stressed 

that ‘‘cottonseed is a uniquely superior 

feed for dairy cattle because it contains 

high concentrations of protein, energy 

(or fat), and fiber; is highly digestible; 

and has proven to increase milk 

production. The commenters argued 

that alternative feeds are not 

‘‘equivalent substitutes’’ because they 

do not contain a similar mix of these 

components and because they are 

generally more expensive. 

The other two comments were 

adverse to EPA’s proposed action. A 

comment from one anonymous 

individual objected to the establishment 

of the tolerance due to the toxic nature 

of methyl bromide and due to potential 

effects on the environment. EPA has 

determined, however, that there would 

be no human dietary exposure from the 

use of methyl bromide to fumigate 

cottonseed. In addition, the safety 

standard for approving tolerances under 

section 408 of the FFDCA focuses on 

potential harm to human health. 

Environmental and non-target species 

considerations are outside of the scope 

of this rule. 

The second comment from another 

individual raised several issues. EPA is 

responding to these issues by topic. 

First, the individual argues that EPA 

should, in collaboration with the United 

States Department of Agriculture 

(USDA), establish the necessity of 

cottonseed as feed for cattle by 

analyzing the supply and demand of 

cottonseed and available alternatives 

prior to approving a methyl bromide 

pesticide tolerance. The commenter also 

asserts that EPA implies that cottonseed 

is the only dairy cattle feed available. 

EPA’s response to this concern is 

twofold. First, and most important, 

EPA’s discussion of the decreased 

availability of cottonseed in the 

proposed rule was included only for the 

purpose of explaining the context of the 

Agency action. It did not provide the 

legal basis for the proposed tolerance. 

The legal standard for the establishment 

of a tolerance is whether the tolerance 

is safe. 21 U.S.C. 346a(b)(2)(A)(i). The 

degree of shortage of cottonseed does 

not affect this safety determination. 

Thus, both this comment and the 

comments from the trade association 

and dairy expert do not address the 

legal basis for establishing the proposed 

methyl bromide tolerance on 

cottonseed. Second, while not relevant 

to the ultimate decision on safety, EPA’s 

statements regarding the current 

shortage of cottonseed were accurate. 

According to USDA, drought conditions 

in Texas have reduced cotton 

production by 13% between the 2010/ 

2011 and 2011/2012 seasons. In 2011, 

the average U.S. yield of cotton per 

harvested acre was the lowest it had 

been since 2003. Moreover, as noted in 

the proposal and as supported by the 


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Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Rules and Regulations 35297 

commenters familiar with the dairy 

industry, cottonseed is an important 

source of protein, energy, and fiber in 

the dairy cattle diet. It generally 

comprises up to 15 percent of the daily 

dietary dry matter intake of lactating 

diary cattle. 

The commenter questions two 

decisions and assumptions made by 

EPA in its decision to establish a 

tolerance: The use of fumigation trials 

on tree nuts as a surrogate for 

cottonseed and the assumption that 

methyl bromide would undergo 

chemical reactions in the digestive 

system of dairy cattle. The Agency 

believes that nuts are an adequate 

surrogate in the case of methyl bromide 

commodity fumigation. In controlled 

trials with numerous commodities, nuts 

had the highest residues of any 

commodity. Studies with other small 

seeds such as poppy seeds and sesame 

seeds showed residues of 35 ppm, in 

contrast to the nuts where a maximum 

residue of 138 ppm was observed. To be 

protective, the Agency chose to translate 

from nuts to cottonseed, since they both 

contain oils. While the Agency does not 

have specific studies on the metabolism 

of methyl bromide in cattle, oral 

metabolism studies in rats have 

indicated methyl bromide undergoes 

chemical transformations in the 

digestive system to compounds that are 

thought to be less toxic. Ruminants such 

as cattle have complex digestive systems 

with four compartments, including a 

fermentation chamber. Therefore, given 

the complexity of the ruminant 

digestive system, there is considerably 

more opportunity for digestion and 

detoxification of a simple molecule such 

as methyl bromide in cattle as compared 

to rats. Finally, the commenter also 

claims that EPA failed to consider the 

impact of methyl bromide pesticide 

levels in cottonseed used as feed on the 

health of livestock. EPA expects methyl 

bromide exposure to cattle to be very 

low. Cottonseed is very unlikely to 

comprise more than 15% of the dairy 

cattle diet and cottonseed and residues 

of methyl bromide in all other potential 

feed items are much lower than the 

levels anticipated in cottonseed. 

Further, residues of methyl bromide in 

the cottonseed will be very low, as the 

residues will largely dissipate after 

fumigation, especially given the time 

needed to ship cottonseed to the United 

States. For commodity fumigations with 

methyl bromide the Agency generally 

sets tolerances based on residue levels 

24 hours after completion of fumigation. 

Commodities such as nuts and 

cottonseed are stored for much longer 

than 24 hours before they are 

distributed for consumption. Controlled 

trials with nuts as well as other 

commodities indicate that residues 

dissipate considerably with time. For 

example, residues in nuts dissipated to 

residues ranging from <0.1 to 11 ppm 

after only 1 week of storage. Mammalian 

oral toxicity studies available to the 

Agency indicate that much higher 

concentrations of methyl bromide in the 

diet would be needed to elicit any sort 

of toxic effect (the maximum reasonable 

dietary burden for dairy cattle is 

approximately 20 ppm (assuming upper 

bound residues), and the no-observed 

effect level in long-term oral toxicity 

studies in rats is approximately 50 

ppm). 

The commenter asserts that approving 

the use of methyl bromide fumigation 

on cottonseed imports will increase 

occupational exposure to methyl 

bromide and requests that EPA weigh 

the risks of occupational exposure 

against the benefits of imported 

cottonseed. However, under the existing 

legal framework provided by section 

408 of the FFDCA EPA is authorized to 

establish pesticide tolerances or 

exemptions where it has been 

demonstrated that the tolerance meets 

the safety standard imposed by that 

statute. In making this determination, 

EPA is specifically prohibited from 

considering occupational exposure to a 

pesticide. 21 U.S.C. 346a(b)(2)(D)(vi). If 

an applicant sought to register methyl 

bromide for use in the United States, the 

issue of risks from occupational 

exposure would be considered by EPA 

in making a determination on 

registration of such a use under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act, 7 U.S.C. 136 et seq. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate analytical method, the 

head-space procedure of King et al. is 

available for enforcement of methyl 

bromide tolerances. Samples are 

blended with water at high speed in 

airtight jars for 5 minutes. After 15 

minutes, the partitioned gas phase is 

sampled and analyzed by gas 

chromatography with electron capture 

detection (GC/EC). See the February 22, 

2002, Residue Chemistry Chapter for the 

methyl bromide RED available in Docket 

EPA–HQ–OPP–2005–0123. 

B. 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 a MRL for methyl bromide 

on cottonseed. 

V. Conclusion 

Based on the information, analysis, 

and conclusions in the April 6, 2012 

proposal (77 FR 20752) (FRL–9345–1), 

as well as the consideration of public 

comments discussed herein, a tolerance 

is established for residues of methyl 

bromide in or on cottonseed at 150 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) on EPA’s 

own initiative. 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). 

Pursuant to the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), the Agency hereby 

certifies that this rule will not have 

significant negative economic impact on 

a substantial number of small entities. 

Establishing a pesticide tolerance or an 


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35298 Federal Register / Vol. 77, No. 114 / Wednesday, June 13, 2012 / Rules and Regulations 

exemption from the requirement of a 

pesticide tolerance is, in effect, the 

removal of a regulatory restriction on 

pesticide residues in food and thus such 

an action will not have any negative 

economic impact on any entities, 

including small entities. 

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 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 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). 

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). 

VII. 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: June 7, 2012. 

Steven Bradbury, 

Director, 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. Add § 180.124 to subpart C to read 

as follows: 

§ 180.124 Methyl Bromide; tolerances for 

residues. 

(a) General. A tolerance is established 

for residues of the fumigant methyl 

bromide, including metabolites and 

degradates, in or on the commodity in 

the table below. Compliance with the 

tolerance level specified below is to be 

determined by measuring only methyl 

bromide. 

Commodity Parts per 

million 

Cotton, undelinted seed ............. 150 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2012–14429 Filed 6–8–12; 4:15 pm] 

BILLING CODE 6560–50–P 


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