46104 Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Rules and Regulations 

Joinus Freight Systems (H.K.) Limited, a.k.a., the 

following two aliases: 

For all items subject to the EAR. 

(See § 744.11 of the EAR).

Presumption of 

denial.

81 FR 14958, 3/21/16. 83 FR [Insert 

FR Page Number] 9/4/2018. 

–JFS Global Logistics; and.

–Joinus Freight Systems Global Logistics Limited.

Unit 07–07, 25F, Tower B, Regent Centre, 63 Wo 

Yi Hop Road, Kwai Chung, N.T. Hong Kong and 

Units 801–803 and 805, Park Sun Building, No. 

97–107 Wo Yi Hop Road, Kwai Chung, Hong 

Kong.

* * * * * 3. On page 44826, in the table, under 

the country heading for Russia, the PJSC 

Mikron entry should read as follows: 

* * * * * 

PJSC Mikron, 1st Zapadniy Proezd 12/1, 

Zelenograd, Russia, 124460.

For all items subject to the EAR. 

(See § 744.11 of the EAR).

Presumption of 

denial.

81 FR 61601, 9/7/16. 83 FR [Insert 

FR Page Number] 9/4/2018. 

* * * * * 

[FR Doc. C2–2018–18766 Filed 9–11–18; 8:45 am] 

BILLING CODE 1301–00–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 110 

[Docket No. FDA–2011–N–0920] 

Current Good Manufacturing Practice, 

Hazard Analysis, and Risk-Based 

Preventive Controls for Human Food 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; partial withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is removing instruction 13 from the 

Current Good Manufacturing Practice, 

Hazard Analysis, and Risk-Based 

Preventive Controls for Human Food 

(Preventive Controls for Human Food) 

regulation. Instruction 13 directs the 

Federal Register to remove and reserve 

as of September 17, 2018, the Current 

Good Manufacturing Practice in 

Manufacturing, Packing, or Holding 

Human Food (Human Food CGMP) 

regulation. Removal of instruction 13 is 

necessary because the compliance dates 

for certain facilities subject to the 

modernized current good manufacturing 

practice requirements in the Preventive 

Controls for Human Food regulation 

have been extended. Retaining the 

Human Food CGMP regulation will 

maintain the status quo while these 

facilities prepare for compliance with 

the new CGMP requirements and will 

avoid an unintended gap in public 

health protection. 

DATES: Effective September 12, 2018, 

FDA withdraws amendatory instruction 

13 on page 56144 of the final rule 

published at 80 FR 55908 at 56144 on 

September 17, 2015. Submit either 

electronic or written comments by 

October 12, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before October 12, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 12, 2018. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2011–N–0920 for ‘‘Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Human Food.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 


daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Rules and Regulations 46105 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Jenny Scott, Center for Food Safety and 

Applied Nutrition (HFS–300), Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2166. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background and Discussion 

II. Legal Authority 

III. Analysis of Environmental Impact 

IV. Paperwork Reduction Act of 1995 

I. Background and Discussion 

In the Federal Register of September 

17, 2015, FDA published the final rule, 

‘‘Current Good Manufacturing Practice, 

Hazard Analysis, and Risk-Based 

Preventive Controls for Human Food’’ 

(80 FR 55908; the ‘‘rule establishing part 

117’’). Among other things, in the final 

rule establishing part 117 (21 CFR part 

117), we modernized and placed in part 

117, subpart B the longstanding current 

good manufacturing practice 

requirements (CGMPs) codified in part 

110 (21 CFR part 110). We staggered the 

compliance dates for part 117 based on 

business size. We also instructed the 

Federal Register to remove and reserve 

part 110 effective September 17, 2018, 

the latest of the staggered compliance 

dates, which we treated as a conforming 

amendment (see instruction number 13 

at 80 FR 55908 at 56144). 

Subsequently, in a final rule 

published in the Federal Register of 

August 24, 2016 (81 FR 57784; the 

‘‘compliance date final rule’’), among 

other things, we extended by up to 16 

months the part 117 compliance dates 

for certain facilities, to address concerns 

about the practicality of compliance, 

consider changes to the regulatory text, 

and better align compliance dates across 

various rules. The compliance date final 

rule extended the part 117 compliance 

dates for the following establishments, 

as set out in table 1: 

TABLE 1—FACILITIES THAT RECEIVED EXTENDED PART 117 COMPLIANCE DATES

Compliance date announced in 

final rule establishing part 117 

Compliance date with extension as 

announced in compliance date 

final rule 

Facility solely engaged in packing and/or holding activities on produce 

RACs, that is: 

• a very small business ................................................................... September 17, 2018 ...................... January 27, 2020. 

• a small business ........................................................................... September 18, 2017 ...................... January 28, 2019. 

• not a small or very small business ............................................... September 19, 2016 ...................... January 26, 2018. 

Facility that would qualify as a secondary activities farm except for 

ownership of the facility, that is: 

• a very small business ................................................................... September 17, 2018 ...................... January 27, 2020. 

• a small business ........................................................................... September 18, 2017 ...................... January 28, 2019. 

• not a small or very small business ............................................... September 19, 2016 ...................... January 26, 2018. 

Facilities that would qualify as a farm if it did not color RACs, that is: 

a very small business ...................................................................... September 17, 2018 ...................... January 27, 2020. 

a small business .............................................................................. September 18, 2017 ...................... January 28, 2019. 

not a small or very small business .................................................. September 19, 2016 ...................... January 26, 2018. 

A small business is a business 

(including any subsidiaries and 

affiliates) employing fewer than 500 

full-time equivalent employees. A very 

small business is a business (including 

any subsidiaries and affiliates) averaging 

less than $1 million, adjusted for 

inflation, per year, during the 3-year 

period preceding the applicable 

calendar year in sales of human food 

plus the market value of human food 

manufactured, processed, packed or 

held without sale (e.g., held for a fee). 

(See § 117.3.) 

After issuing the compliance date 

final rule, FDA announced that as a 

matter of enforcement policy it did not 

intend to enforce certain part 117 

requirements for certain facilities, 

including some of the facilities in table 

1 whose compliance dates had been 

extended by the compliance date final 

rule. See the January 2018 guidance 

entitled ‘‘Policy Regarding Certain 

Entities Subject to the Current Good 

Manufacturing Practice and Preventive 

Controls, Produce Safety, and/or 

Foreign Supplier Verification Programs’’ 

(https://www.fda.gov/downloads/food/ 

guidanceregulation/guidancedocuments

regulatoryinformation/ucm590661.pdf). 

The present rulemaking does not change 

the policies contained in this guidance. 

As mentioned above, in the final rule 

establishing part 117 we instructed the 

Federal Register to remove and reserve 

part 110, effective September 17, 2018, 

which at the time was the latest of the 

staggered compliance dates. The goal 

was to have firms subject to the Human 

Food CGMP regulation until the 

Preventive Controls for Human Food 

regulation took its place, leaving no gap 

in public health protection. However, in 

the compliance date final rule we 

extended the compliance dates for part 

117 by up to 16 months but failed to 


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46106 Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Rules and Regulations 

revise the previous instruction to 

remove part 110. Without the current 

action, the small and very small 

facilities described in table 1 will not be 

subject to any CGMPs until, 

respectively, January 28, 2019, and 

January 27, 2020. However, FDA’s 

intent always has been that part 110 

would remain unchanged and in effect 

until all establishments have reached 

the date when they must be in 

compliance with part 117. Therefore, we 

are amending the rule establishing part 

117 to remove the instruction to the 

Federal Register to remove and reserve 

part 110. We intend to remove part 110 

in a separate action after all 

establishments have reached their 

compliance dates for the part 117 

CGMPs. 

When FDA conducts rulemaking, it 

normally does so using notice-andcomment procedures established under 

the Administrative Procedure Act (APA) 

and FDA regulations. These procedures 

allow the public an opportunity to 

participate in Agency rulemaking by 

submitting written comments on 

proposed rules. FDA considers these 

comments as it finalizes rules. (5 U.S.C. 

553(b) and (c); § 10.40 (21 CFR 10.40.)) 

The APA, however, does not require an 

agency to use notice-and-comment 

procedures in all rulemaking. For 

example, the APA provides that 

Agencies shall not use notice-andcomment procedures, and shall proceed 

with a final rule, when the Agency for 

good cause finds that notice and public 

procedure thereon are impracticable, 

unnecessary, or contrary to public 

interest, and incorporates the finding 

and a brief statement of reasons therefor 

in the rules issued. (5 U.S.C. 553(b)(B).) 

Likewise, FDA’s regulations provide 

that the requirements of notice and 

public procedure do not apply when the 

Commissioner of Food and Drugs 

determines for good cause that they are 

impracticable, unnecessary, or contrary 

to the public interest, in which case, the 

notice issuing the regulation will state 

the reasons for the determination, and 

provide an opportunity for comment to 

determine whether the regulation 

should subsequently be modified or 

revoked. (§ 10.40(e)(1).) Pursuant to this 

regulation, FDA requests comments on 

the timing for the removal of part 110. 

In this instance, for several reasons, 

FDA finds good cause for issuing this 

final rule without notice and comment. 

Notice and comment are unnecessary 

because this final rule is a minor and 

technical repair of an obvious oversight 

in the compliance date final rule, 

maintains the CGMP regulatory status 

quo for industry, affirms FDA’s plan for 

transitioning from part 110 to part 117 

as outlined in the rule establishing part 

117, and is not expected to generate 

public concern. FDA is addressing the 

gap in CGMP regulatory coverage from 

September 17, 2018, to January 27, 

2020, by issuing a narrowly tailored 

amendment to remove instruction 13 

from the rule to establish part 117. The 

result of this amendment will be that 

the part 110 CGMPs will continue in 

effect for establishments that have not 

reached their part 117 compliance date. 

This action will serve to correct an 

obvious oversight made in the 

compliance date final rule. FDA does 

not anticipate public concern with this 

action. The Agency previously sought 

public comment on its proposal to 

remove part 110 in coordination with 

the compliance dates for part 117 and 

received no comments that disagreed. 

The present continuation and planned 

eventual removal of part 110 is a repeat 

of what was previously proposed 

without public objection. Furthermore, 

it is clear from the rule establishing part 

117 that we intended for facilities to 

remain subject to part 110 until their 

part 117 compliance date (80 FR 55908 

at 56127). Thus, we do not believe there 

was ever any reasonable expectation on 

the part of the establishments listed in 

table 1 that they would not be 

continuously subject to CGMPs. For 

these various reasons, we have 

determined that notice and comment is 

unnecessary. 

FDA finds further good cause for 

issuing this final rule without notice 

and comment because notice and 

comment are contrary to the public 

interest and impracticable. There could 

be negative public health implications if 

there were a temporal gap in CGMP 

coverage; for example, there have been 

outbreaks associated with the types of 

facilities still subject to part 110 (e.g., 

listeria in cantaloupe). Many of the 

establishments listed in table 1 are not 

required to comply with the 

replacement CGMPs in part 117 until 

January 2019 or January 2020, 

depending on business size. This means 

that these establishments would have no 

applicable CGMP requirements for 4 to 

16 months. CGMP requirements have 

existed for all human food 

manufacturers since at least 1970 (see 

34 FR 6977) and serve as a significant 

basis for FDA’s determination of what 

constitutes an insanitary food 

production environment that may result 

in food that is injurious to public health 

under section 402(a)(4) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

342(a)(4)), among other authorities. It 

would be contrary to the public interest 

to allow the temporal gap in CGMP 

coverage. 

To summarize, a gap in CGMP 

coverage would leave FDA without a 

primary tool to execute its function of 

ensuring that food manufacturing 

establishments follow basic food safety 

practices, potentially endangering the 

public health, in order to provide the 

public an opportunity to comment on a 

non-controversial technical matter. For 

these reasons, we are issuing this 

amendment to the final rule establishing 

part 117 without prior notice and 

comment. (5 U.S.C. 553(b)(3)(B)). 

In addition, we find good cause for 

this amendment to the rule establishing 

part 117 to become effective on the date 

of publication. The APA allows an 

effective date less than 30 days after 

publication as provided by the Agency 

for good cause found and published 

within the rule (5 U.S.C. 553(d)(3)). As 

provided at 80 FR 55908, September 17, 

2015, the amendment removing part 110 

was to take effect on September 17, 

2018. In order to continue part 110 for 

an interim period, this final rule needs 

to be effective on or before September 

16, 2018, and therefore it is not possible 

for this rule to take effect 30 days after 

publication in the Federal Register. As 

previously described, in order to 

prevent a gap in CGMP coverage for 

certain establishments, an immediate 

effective date is necessary to remove, 

before September 17, 2018, the 

instruction to remove and reserve part 

110. Further, because the facilities’ 

responsibility to comply with CGMP 

requirements remains unchanged, this 

rule places no burden on affected 

parties for which they would need a 

reasonable time to prepare. Therefore, 

the Commissioner finds good cause 

under 5 U.S.C. 553(d)(3) and 

§ 10.40(c)(4)(ii) for this amendment to 

become effective on the date of 

publication. 

II. Legal Authority 

We are issuing this final rule 

removing instruction number 13 of the 

rule to establish part 117 under the 

same authority for which the rule 

containing instruction number 13 was 

originally issued. That analysis may be 

found in section II, ‘‘Legal Authority,’’ 

of the rule to establish part 117 (80 FR 

55908 at 55917 to 55920). 

III. Analysis of Environmental Impact 

FDA has determined that the removal 

of instruction 13 will not change the 

status quo and, therefore, is not a major 

Federal action significantly affecting the 

quality of the human environment 

within the meaning of section 102(2)(C) 

of the National Environmental Policy 


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Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Rules and Regulations 46107 

Act (42 U.S.C. 4321 et seq.). Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

IV. Paperwork Reduction Act of 1995 

This final rule contains no collection 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required. 

List of Subjects in 21 CFR Part 110 

Food packaging, Foods. 

■ Therefore, in FR Rule Doc. No. 2015– 

21920, published September 17, 2015, at 

80 FR 55908–56168, amendatory 

instruction 13 in the third column on 

page 56144 is withdrawn. 

Dated: September 7, 2018. 

Scott Gottlieb, 

Commissioner of Food and Drugs. 

[FR Doc. 2018–19855 Filed 9–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 60, 61, and 63 

[EPA–R06–OAR–2016–0091; FRL–9982– 

62—Region 6] 

New Source Performance Standards 

and National Emission Standards for 

Hazardous Air Pollutants; Delegation 

of Authority to New Mexico 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; delegation of 

authority. 

SUMMARY: The New Mexico 

Environment Department (NMED) has 

submitted updated regulations for 

receiving delegation and approval of a 

program for the implementation and 

enforcement of certain New Source 

Performance Standards (NSPS) and 

National Emission Standards for 

Hazardous Air Pollutants (NESHAP) for 

all sources (both Title V and non-Title 

V sources). These updated regulations 

apply to certain NSPS promulgated by 

the EPA and amended between 

September 24, 2013 and January 15, 

2017; certain NESHAP promulgated by 

the EPA and amended between January 

1, 2011 and January 15, 2017; and other 

NESHAP promulgated by the EPA and 

amended between August 30, 2013 and 

January 15, 2017, as adopted by the 

NMED. The delegation of authority 

under this action does not apply to 

sources located in Bernalillo County, 

New Mexico, or to sources located in 

areas defined as Indian Country. The 

EPA is providing notice that it is 

updating the delegation of certain NSPS 

to NMED, and taking final action to 

approve the delegation of certain 

NESHAP to NMED. 

DATES: This rule is effective on October 

12, 2018. 

ADDRESSES: The EPA has established a 

docket for this action under Docket ID 

No. EPA–R06–OAR–2016–0091. All 

documents in the docket are listed on 

the http://www.regulations.gov website. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

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 

electronically through http://

www.regulations.gov or in hard copy at 

the EPA Region 6, 1445 Ross Avenue, 

Suite 700, Dallas, Texas 75202–2733. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Rick Barrett (6MM–AP), (214) 665–7227; 

email: barrett.richard@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document whenever 

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

the EPA. 

Table of Contents 

I. Background 

II. Response to Comment 

III. What does this action do? 

IV. What is the authority for delegation? 

V. What criteria must New Mexico’s 

programs meet to be approved? 

VI. How did NMED meet the NSPS and 

NESHAP program approval criteria? 

VII. What is being delegated? 

VIII. What is not being delegated? 

IX. How will statutory and regulatory 

interpretations be made? 

X. What authority does the EPA have? 

XI. What information must NMED provide to 

the EPA? 

XII. What is the EPA’s oversight role? 

XIII. Should sources submit notices to the 

EPA or NMED? 

XIV. How will unchanged authorities be 

delegated to NMED in the future? 

XV. Final Action 

XVI. Statutory and Executive Order Reviews 

I. Background 

On April 13, 2018, EPA published a 

direct final rule and accompanying 

proposal approving the updated 

delegation of authority for 

implementation and enforcement of 

NSPS and NESHAPs for all sources 

(both part 70 and non-part 70 sources) 

to the NMED. The direct final rule and 

proposal were published without prior 

proposal because EPA anticipated no 

relevant adverse comments. See 83 FR 

15964 and 83 FR 16027, respectively. 

EPA stated in the direct final rule that 

if we receive relevant adverse comments 

by May 14, 2018, we would publish a 

timely withdrawal in the Federal 

Register, and all public comments 

received would be addressed in a 

subsequent final rule based on the 

proposed rule. 

EPA received an adverse comment on 

May 14, 2018, and accordingly 

withdrew the direct final rule on June 

5, 2018, pursuant to sections 111 and 

112 of the CAA. See 83 FR 25936. The 

comment and our response to that 

comment follows below. 

II. Response to Comment 

Comment: EPA received an 

anonymous adverse comment in 

response to the proposed rulemaking. 

The comment includes several personal 

observations and statements critical of 

New Mexico’s ability to maintain and 

oversee its air quality programs. The 

commenter recommends that the 

proposed update to New Mexico’s 

NESHAP delegation not be approved 

until EPA investigates the commenter’s 

allegations and New Mexico has 

addressed the alleged deficiencies. See 

Docket for the entire comment. 

EPA’s Response: We thank the 

commenter for the comment. Section 

112(l) of the Act and EPA’s 

implementing regulations at 40 CFR part 

63, subpart E primarily govern EPA’s 

actions on State requests for delegation 

of authority to implement and enforce 

the NESHAP program. CAA section 

112(l)(5)(B) states that EPA shall 

disapprove a NESHAP program 

submitted by a State if we find that 

adequate resources are not available to 

implement the program. See also 40 

CFR 63.91(d)(3)(iii). Several concerns 

expressed by the commenter relate to 

the adequacy of resources (including the 

lack of technically experienced and 

qualified staff) maintained by the NMED 

Air Quality Bureau. NMED provided 

EPA with a response to those comments 

that included a description of current 

resources and experience within the Air 

Quality Bureau. See Docket for NMED’s 

response. In addition, consistent with 

40 CFR 63.91(d)(2), New Mexico’s 

delegation update request included a 

reference to its previous demonstration 

and a reaffirmation that the up-front 

approval criteria for delegation are still 

being met. Based on this information as 

well as discussions with the 

Compliance and Enforcement Division 

and the Criminal Investigation Division 

within EPA Region 6, we have not 

identified sufficient information to 

support the necessary finding for 

disapproval of the requested NESHAP 


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