Federal Register / Vol. 78, No. 160 / Monday, August 19, 2013 / Proposed Rules 50359 

FOR FURTHER INFORMATION CONTACT: 

Annette McCarthy, Center for Food 

Safety and Applied Nutrition (HFS– 

205), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 240–402–1200. 

SUPPLEMENTARY INFORMATION: To 

minimize the risk of serious adverse 

health consequences or death from 

consumption of contaminated produce, 

FDA has published the proposed rule, 

Standards for Growing, Harvesting, 

Packing, and Holding of Produce for 

Human Consumption (‘‘the produce 

safety rule’’ or ‘‘the proposed rule’’) to 

establish science-based minimum 

standards for the safe growing, 

harvesting, packing, and holding of 

produce, meaning fruits and vegetables 

grown for human consumption (78 FR 

3504, January 16, 2013). FDA has 

proposed these standards as part of our 

implementation of the FDA Food Safety 

Modernization Act (FSMA). These 

standards would not apply to produce 

that is rarely consumed raw, produce for 

personal or on-farm consumption, or 

produce that is not a raw agricultural 

commodity. In addition, produce that 

receives commercial processing that 

adequately reduces the presence of 

microorganisms of public health 

significance would be eligible for 

exemption from the requirements of this 

rule. The proposed rule would set forth 

procedures, processes, and practices 

that minimize the risk of serious adverse 

health consequences or death, including 

those reasonably necessary to prevent 

the introduction of known or reasonably 

foreseeable biological hazards into or 

onto produce and to provide reasonable 

assurances that the produce is not 

adulterated on account of such hazards. 

We expect that the proposed rule, if 

finalized as proposed, would reduce 

foodborne illness associated with the 

consumption of contaminated produce. 

For the proposed rule, the Agency 

relied on a categorical exclusion from 

the need to prepare an Environmental 

Assessment or EIS under 21 CFR 

25.30(j). Based on currently available 

information, including comments 

received, and upon further analysis, 

FDA has determined that the proposed 

action may significantly affect the 

quality of the human environment (21 

CFR 25.22(b)) and, therefore, an EIS is 

necessary for the final rule. For 

example, switching from surface to 

ground water was originally considered 

a cost- and time-prohibitive option that 

was unlikely to occur to any significant 

extent given that monitoring data 

available prior to the publication of the 

proposed rule showed that Escherichia. 

coli exceedance of the proposed 

standard occurred during 5 percent of 

the monitoring period with 55 percent 

of the incidents being no more than 2 

days, as discussed in the categorical 

exclusion memo (see Ref. 266 of the 

proposed rule). Public comment, 

subsequent to the publication of the 

proposed rule, has indicated that in 

some regions current irrigation practices 

use water that is unlikely to meet the 

proposed microbial standards for much, 

if not all of the growing season. 

Consequently, if such standards are 

finalized, ground water is likely to be 

explored as a more viable alternative 

water source for irrigation in these 

regions than previous information had 

indicated. Given recently highlighted 

concerns of ground water depletion 

(Ref. 1), FDA has determined that the 

use of ground water for irrigation, in 

response to a microbial standard, may 

significantly affect the quality of the 

human environment. Similarly, 

comments received caused FDA to 

reevaluate the proposed requirements 

for biological soil amendments of 

animal origin, which propose an 

increasingly stringent set of application 

restrictions based on the likelihood of 

the soil amendment harboring 

pathogens. These proposed 

requirements, if finalized, are expected 

to result in changes in current use of 

treated and untreated biological soil 

amendments of animal origin or 

potentially greater use of synthetic 

fertilizers. Changes in the type or 

handling of soil amendments may 

significantly affect the quality of the 

human environment. 

The purpose of the public scoping 

process for the EIS is to determine 

relevant issues that will influence the 

scope of the environmental analysis, 

including potential alternatives, and the 

extent to which those issues and 

impacts will be analyzed in the EIS. The 

EIS will be prepared in accordance with 

section 102(2)(C) of NEPA (Pub. L. 91– 

190), FDA’s NEPA implementing 

regulations (21 CFR Part 25), and the 

CEQ regulations for implementing 

NEPA (40 CFR Parts 1500–1508). 

Federal, State, and local Agencies, along 

with tribes and other stakeholders that 

may be interested in or affected by the 

produce safety rule are invited to 

participate in the scoping process. Some 

Federal Agencies may request or be 

requested by the FDA to participate in 

the development of the environmental 

analysis as a cooperating agency. FDA 

has previously sought comment on 

potential environmental effects as part 

of the public comment period for the 

proposed rule, including specific 

questions regarding agricultural water, 

biological soil amendments of animal 

origin, and wildlife (78 FR 3504 at 3616, 

3619–3620). FDA believes that these 

questions are still relevant to the 

environmental analysis and will 

consider comments received. FDA 

encourages additional comments, as 

part of this scoping process, on what 

specific issues, alternatives, mitigation 

measures, or other information FDA 

should include for further analysis in 

the EIS for the produce safety rule. 

References 

The following reference has been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. (FDA has verified the 

Web site address, but FDA is not 

responsible for any subsequent changes 

to the Web site after this document 

publishes in the Federal Register.) 

1. U.S. Geological Survey. 2013. 

Groundwater Depletion in the United States 

(1900–2008). Scientific Investigation Report 

2013–5079. Available at: http://

pubs.usgs.gov/sir/2013/5079/SIR2013- 

5079.pdf. Accessed July 30, 2013. 

Dated: August 13, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–20087 Filed 8–16–13; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[DOD–2011–HA–0136] 

RIN 0720–AB56 

Civilian Health and Medical Program of 

the Uniformed Services (CHAMPUS); 

TRICARE Uniform Health Maintenance 

Organization (HMO) Benefit—Prime 

Enrollment Fee Exemption for 

Survivors of Active Duty Deceased 

Sponsors and Medically Retired 

Uniformed Services Members and 

Their Dependents; Withdrawal 

AGENCY: Office of the Secretary, DoD. 

ACTION: Proposed rule; withdrawal. 

SUMMARY: On Thursday, August 8, 2013 

(78 FR 48366–48367), the Department of 

Defense published a proposed rule titled 

‘‘Civilian Health and Medical Program 

of the Uniformed Services (CHAMPUS); 

TRICARE Uniform Health Maintenance 

Organization (HMO) Benefit—Prime 

Enrollment Fee Exemption for Survivors 

of Active Duty Deceased Sponsors and 

Medically Retired Uniformed Services 


pmangrum on DSK3VPTVN1PROD with PROPOSALS-1
50360 Federal Register / Vol. 78, No. 160 / Monday, August 19, 2013 / Proposed Rules 

Members and Their Dependents.’’ 

Subsequent to the publication of the 

proposed rule in the Federal Register, 

DoD discovered that an identical 

proposed rule published in the Federal 

Register on Friday, June 7, 2013 (78 FR 

34292–34293). DoD is hereby 

withdrawing the proposed rule that 

published in the Federal Register on 

Thursday, August 8, 2013. 

DATES: As of August 19, 2013 the 

proposed rule published August 8, 2013 

(78 FR 48366–48367), is withdrawn. 

FOR FURTHER INFORMATION CONTACT: 

Patricia Toppings, 571–372–0485. 

Dated: August 14, 2013. 

Aaron Siegel, 

Alternate OSD Federal Register Liaison 

Officer, Department of Defense. 

[FR Doc. 2013–20121 Filed 8–16–13; 8:45 am] 

BILLING CODE 5001–06–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R05–OAR–2011–0888; EPA–R05– 

OAR–2011–0969; EPA–R05–OAR–2012– 

0567; EPA–R05–OAR–2012–0988; FRL– 

9900–19–Region 5] 

Approval and Promulgation of Air 

Quality Implementation Plans; Indiana; 

Infrastructure SIP Requirements for 

the 2008 Lead and Ozone National 

Ambient Air Quality Standards; Indiana 

PSD; Indiana State Board 

Requirements 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to approve 

elements of state implementation plan 

(SIP) submissions by Indiana regarding 

the infrastructure requirements of 

sections 110(a)(1) and (2) of the Clean 

Air Act (CAA) for the 2008 lead and 

2008 8-hour ground level ozone national 

ambient air quality standards (2008 Pb 

and ozone NAAQS). The infrastructure 

requirements are designed to ensure that 

the structural components of each 

state’s air quality management program 

are adequate to meet the state’s 

responsibilities under the CAA. EPA is 

also proposing to approve portions of 

submissions from Indiana addressing 

EPA’s requirements for the prevention 

of significant deterioration (PSD) 

program. Lastly, EPA is proposing to 

approve a submission from Indiana 

addressing the state board requirements 

under section 128 of the CAA. 

DATES: Comments must be received on 

or before September 18, 2013. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R05– 

OAR–2011–0888 (2008 Pb infrastructure 

SIP elements), EPA–R05–OAR–2011– 

0969 (2008 ozone infrastructure SIP 

elements), EPA–R05–OAR–2012–0567 

(PSD elements), or EPA–R05–OAR– 

2012–0988 (state board requirements), 

by one of the following methods: 

1. www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

2. Email: aburano.douglas@epa.gov. 

3. Fax: (312) 408–2279. 

4. Mail: Douglas Aburano, Chief, 

Attainment Planning and Maintenance 

Section, Air Programs Branch (AR–18J), 

U.S. Environmental Protection Agency, 

77 West Jackson Boulevard, Chicago, 

Illinois 60604. 

5. Hand Delivery: Douglas Aburano, 

Chief, Attainment Planning and 

Maintenance Section, Air Programs 

Branch (AR–18J), U.S. Environmental 

Protection Agency, 77 West Jackson 

Boulevard, Chicago, Illinois 60604. 

Such deliveries are only accepted 

during the Regional Office normal hours 

of operation, and special arrangements 

should be made for deliveries of boxed 

information. The Regional Office official 

hours of business are Monday through 

Friday, 8:30 a.m. to 4:30 p.m., excluding 

Federal holidays. 

Instructions: Direct your comments to 

Docket ID. EPA–R05–OAR–2011–0888 

(2008 Pb infrastructure SIP elements), 

EPA–R05–OAR–2011–0969 (2008 ozone 

infrastructure SIP elements), EPA–R05– 

OAR–2012–0567 (PSD elements), or 

EPA–R05–OAR–2012–0988 (state board 

requirements). EPA’s policy is that all 

comments received will be included in 

the public docket without change and 

may be made available online at 

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 www.regulations.gov 

or email. The www.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 www.regulations.gov your email 

address will be automatically captured 

and included as part of the comment 

that is placed in the public 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 www.regulations.gov 

index. 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, will be publicly 

available only in hard copy. Publicly 

available docket materials are available 

either electronically in 

www.regulations.gov or in hard copy at 

the U.S. Environmental Protection 

Agency, Region 5, Air and Radiation 

Division, 77 West Jackson Boulevard, 

Chicago, Illinois 60604. This facility is 

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

Monday through Friday, excluding 

Federal holidays. We recommend that 

you telephone Andy Chang, 

Environmental Engineer, at (312) 886– 

0258 before visiting the Region 5 office. 

FOR FURTHER INFORMATION CONTACT: 

Andy Chang, Environmental Engineer, 

Attainment Planning and Maintenance 

Section, Air Programs Branch (AR–18J), 

U.S. Environmental Protection Agency, 

Region 5, 77 West Jackson Boulevard, 

Chicago, Illinois 60604, (312) 886–0258, 

chang.andy@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document whenever 

‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean 

EPA. This supplementary information 

section is arranged as follows: 

I. What should I consider as I prepare my 

comments for EPA? 

II. What is the background of these SIP 

submissions? 

A. What state SIP submissions does this 

rulemaking address? 

B. Why did the state make these SIP 

submissions? 

C. What is the scope of this rulemaking? 

III. What guidance is EPA using to evaluate 

these SIP submissions? 

IV. What is the result of EPA’s review of 

these SIP submissions? 

A. Section 110(a)(2)(A)—Emission Limits 

and Other Control Measures 

B. Section 110(a)(2)(B)—Ambient Air 

Quality Monitoring/Data System 

C. Section 110(a)(2)(C)—Program for 

Enforcement of Control Measures; PSD 

D. Section 110(a)(2)(D)—Interstate 

Transport 

E. Section 110(a)(2)(E)—Adequate 

Resources 

F. Section 110(a)(2)(F)—Stationary Source 

Monitoring System 


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