17972 Federal Register / Vol. 79, No. 61 / Monday, March 31, 2014 / Proposed Rules 

1Title XXXIII of the PHS Act is codified at 42 

U.S.C. 300mm to 300mm–61. Those portions of the 

Zadroga Act found in Titles II and III of Public Law 

111–347 do not pertain to the WTC Health Program 

and are codified elsewhere. 

2See Petition 003. WTC Health Program: Petitions 

Received. http://www.cdc.gov/wtc/received.html. 

establish exemptions from the 

requirement of a tolerance in or on all 

raw agricultural commodities. On 

January 21, 2014, Loveland Products, 

Inc., notified EPA that it was 

withdrawing this petition. 

4. PP 3E8170 (Chlorantraniliprole). 

EPA issued a notice in the Federal 

Register of July 19, 2013 (78 FR 43115) 

(FRL–9392–9) (EPA–HQ–OPP–2013– 

0235), which announced the filing of 

pesticide petition (PP 3E8170) by 

Interregional Research Project Number 4 

(IR–4). The petition proposed to 

establish a tolerance in 40 CFR part 

180.628 for residues of the insecticide 

chlorantraniliprole in or on fruit, stone, 

group 12–12, except cherry, chickasaw 

plum, and damson plum at 4.0 ppm; 

nut, tree, group 14–12 at 0.04 ppm; 

papaya at 4.0 ppm; passionfruit at 4.0 

ppm; and onion, green, subgroup 3–07B 

at 3.0 ppm. On January 28, 2014, IR–4 

notified EPA that it was withdrawing 

the proposed tolerance in or on nut, 

tree, group 14–12 from this petition. 

5. PP 9E7621 (Alkyl Polyglucoside 

Esters (AGEs)). EPA issued a notice in 

the Federal Register of March 24, 2010 

(75 FR 14154) (EPA–HQ–OPP–2010– 

0138), which announced the filing of a 

pesticide petition (PP 9E7621) by 

Lamberti USA, Inc., 161 Washington St., 

Conshohocken, PA 19428. The petition 

requested to establish an exemption 

from the requirement of a tolerance for 

residues of alkyl polyglucoside esters 

(AGEs) group, formed by DGlucopyranose, oligomeric, 6- 

(dihydrogen 2-hydroxy-1,2,3- 

propanetricarboxylate), 1-(C8-C20 linear 

and branched alkyl) ethers, sodium salts 

(CAS No. 1079993–97–7); DGlucopyranose, oligomeric, 6-(hydrogen 

sulfobutanedioate), 1-(C8-C20 linear and 

branched alkyl) ethers, sodium salts 

(CAS No. 1079993–92–2); DGlucopyranose, oligomeric, Propanoic 

acid, 2-hydroxy-, 1-(C8-C20 linear and 

branched alkyl) ethers (CAS No. 

1079993–94–4); under 40 CFR 180.910 

and 40 CFR 180.920 in or on raw 

agricultural commodities, when used as 

a pesticide inert in final pesticide 

formulations. On February 11, 2014, 

Lamberti USA, Inc., notified EPA that it 

was withdrawing this petition. 

6. PP 2E8093 (sodium metabisulfite). 

EPA issued a notice in the Federal 

Register of June 5, 2013 (78 FR 33785) 

(EPA–HQ–OPP–2013–0175), which 

announced the filing of a pesticide 

petition (PP 2E8093) by Winfield 

Solutions, LLC, P.O. Box 64589, St. 

Paul, MN 55164. The petition requested 

to establish an exemption from the 

requirement of a tolerance for residues 

of sodium metabisulfite (CAS No. 7681– 

57–4) under 40 CFR 180.920 in or on 

raw agricultural commodities, when 

used as a pesticide inert ingredient 

(preservative) at concentrations less 

than 0.5% of the total formulation and 

applied to growing crops only. On 

February 14, 2014, Winfield Solutions 

notified EPA that it was withdrawing 

this petition. 

List of Subjects 

Environmental protection, 

Agricultural commodities, Feed 

additives, Food additives, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: March 6, 2014. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

[FR Doc. 2014–05693 Filed 3–28–14; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 88 

World Trade Center Health Program; 

Petition 003—Kidney Damage; Finding 

of Insufficient Evidence 

AGENCY: Centers for Disease Control and 

Prevention, HHS. 

ACTION: Denial of petition for addition of 

a health condition. 

SUMMARY: On January 22, 2014, the 

Administrator of the World Trade 

Center (WTC) Health Program received 

a petition to add ‘‘kidney damage’’ 

(Petition 003) to the List of WTC-Related 

Health Conditions (List). The 

Administrator has not found sufficient 

scientific evidence to conduct an 

analysis of whether to add kidney 

damage and/or disease to the List. 

Accordingly, the Administrator finds 

that insufficient evidence exists to 

request a recommendation of the WTC 

Health Program Scientific/Technical 

Advisory Committee (STAC), to publish 

a proposed rule, or to publish a 

determination not to publish a proposed 

rule. 

DATES: The Administrator of the WTC 

Health Program is denying this petition 

for the addition of a health condition as 

of March 31, 2014. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Weiss, Program Analyst, 4674 

Columbia Parkway, MS: C–46, 

Cincinnati, OH 45226; telephone (855) 

818–1629 (this is a toll-free number); 

email NIOSHregs@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

A. WTC Health Program Statutory 

Authority 

Title I of the James Zadroga 9/11 

Health and Compensation Act of 2010 

(Pub. L. 111–347), amended the Public 

Health Service Act (PHS Act) to add 

Title XXXIII 1 establishing the WTC 

Health Program within the Department 

of Health and Human Services (HHS). 

The WTC Health Program provides 

medical monitoring and treatment 

benefits to eligible firefighters and 

related personnel, law enforcement 

officers, and rescue, recovery, and 

cleanup workers (responders) who 

responded to the September 11, 2001, 

terrorist attacks in New York City, at the 

Pentagon, and in Shanksville, 

Pennsylvania, and to eligible persons 

(survivors) who were present in the dust 

or dust cloud on September 11, 2001 or 

who worked, resided, or attended 

school, childcare, or adult daycare in 

the New York City disaster area. 

All references to the Administrator of 

the WTC Health Program 

(Administrator) in this notice mean the 

Director of the National Institute for 

Occupational Safety and Health 

(NIOSH) or his or her designee. 

Pursuant to § 3312(a)(6)(B) of the PHS 

Act, interested parties may petition the 

Administrator to add a health condition 

to the List in 42 CFR 88.1. Within 60 

calendar days after receipt of a petition 

to add a condition to the List, the 

Administrator must take one of the 

following four actions described in 

§ 3312(a)(6)(B) and 42 CFR 88.17: (i) 

request a recommendation of the STAC; 

(ii) publish a proposed rule in the 

Federal Register to add such health 

condition; (iii) publish in the Federal 

Register the Administrator’s 

determination not to publish such a 

proposed rule and the basis for such 

determination; or (iv) publish in the 

Federal Register a determination that 

insufficient evidence exists to take 

action under (i) through (iii) above. 

B. Petition 003 

On January 22, 2014, the 

Administrator received a petition to add 

‘‘kidney damage’’ to the List (Petition 

003).2 The petition was submitted by a 

Fire Department of New York (FDNY) 

firefighter who worked at Ground Zero 

in the aftermath of the September 11, 

2001, terrorist attacks. The petitioner 

indicated that he had been diagnosed 

with kidney failure and shared a letter 


emcdonald on DSK67QTVN1PROD with PROPOSALS
Federal Register / Vol. 79, No. 61 / Monday, March 31, 2014 / Proposed Rules 17973 

3Mount Sinai Hospital [November 9, 2013]. 

Kidney Damage in First Responders Linked to 

September 11. http://www.mountsinai.org/aboutus/newsroom/press-releases/kidney-damage-infirst-responders-linked-to-september-11. 

4McLaughlin MA, Sanghavi S, Maceda C, 

Woodward M, Crowley LE, Wyatt CM [2013]. New 

Evidence that Particulate Matter Exposure at 

Ground Zero is Associated with Kidney Damage.’’ 

J Am Soc Nephrol 24:663A. See http://www.asnonline.org/education/kidneyweek/archives/. 

5This methodology, ‘‘Policy and Procedures for 

Adding Non-Cancer Conditions to the List of WTCRelated Health Conditions,’’ is available on the 

WTC Health Program Web site, at http://www.cdc.

gov/wtc/policies.html. 

6The substantial evidence standard is met when 

the Program assesses all of the available, relevant 

information and determines with high confidence 

that the evidence supports its findings regarding a 

causal association between the 9/11 exposure(s) and 

the health condition. 

7The modest evidence standard is met when the 

Program assesses all of the available, relevant 

information and determines with moderate 

confidence that the evidence supports its findings 

regarding a causal association between the 9/11 

exposure(s) and the health condition. 

from his nephrologist explaining that he 

has ‘‘chronic kidney disease with 

unknown oetiology [sic].’’ Also 

included in his petition was a press 

release issued by the WTC–CHEST 

Program at Icahn School of Medicine at 

Mount Sinai (Mount Sinai) describing a 

forthcoming study by Mary Ann 

McLaughlin and others, finding a 

‘‘significant link between a high level of 

exposure to particulate matter by first 

responders at Ground Zero and the 

increased level of the protein albumin 

in their urine.’’ 3 The anticipated study 

findings are described in an abstract 

supplement to the Journal of the 

American Society of Nephrology.4

C. Administrator’s Determination on 

Petition 003 

The Administrator has established a 

methodology for evaluating whether to 

add non-cancer health conditions to the 

List of WTC-Related Health Conditions.5

A health condition may be added to the 

List if published, peer-reviewed 

epidemiologic evidence provides 

substantial support for a causal 

relationship between 9/11 exposures 

and the health condition in 9/11- 

exposed populations.6 If the 

epidemiologic evidence provides 

modest support for a causal relationship 

between 9/11 exposures and the health 

condition, the Administrator may then 

evaluate studies of associations between 

the health condition and 9/11 agents.7 If 

that additional assessment establishes 

substantial support for a causal 

relationship between a 9/11 agent or 

agents and the health condition, the 

health condition may be added to the 

List. 

In accordance with § 3312(a)(6)(B) of 

the PHS Act and 42 CFR 88.17, 

described above, the Administrator has 

reviewed the evidence presented in 

Petition 003. The Administrator has also 

conducted a search of the existing 

scientific/medical literature for 

evidence that could establish a causal 

relationship between 9/11 exposure and 

kidney damage/disease. He did not find 

any peer-reviewed, published 

epidemiologic studies of 9/11-exposed 

populations supporting such an 

relationship. While the information 

reported in the McLaughlin et al. 

abstract is an important first step in 

scientific inquiry, the Administrator 

finds that an abstract is insufficient to 

serve as the scientific basis for adding 

an entire class of health conditions— 

chronic kidney damage/disease—to the 

List. 

Because the McLaughlin et al. abstract 

is found to be insufficient to 

scientifically support the further 

consideration of kidney damage/disease 

and because it is clear to the 

Administrator that the scientific 

literature on 9/11 exposed-populations 

does not support a causal relationship 

between that exposure and kidney 

damage/disease, the Administrator has 

determined that requesting a 

recommendation from the STAC 

(pursuant to PHS Act, § 3312(a)(6)(B)(i) 

and 42 CFR 88.17(a)(2)(i)) is 

unwarranted. In prior actions, the 

Administrator requested a 

recommendation from the STAC when 

he determined that it would assist his 

evaluation; such as when, for example, 

the Administrator is in need of an 

interpretation of conflicting or 

inconclusive published scientific 

evidence. 

Similarly, the Administrator has 

determined that insufficient evidence 

exists to take further action, including 

either proposing the addition of kidney 

damage/disease to the List (pursuant to 

PHS Act, § 3312(a)(6)(B)(ii) and 42 CFR 

88.17(a)(2)(ii)) or publishing a 

determination not to publish a proposed 

rule in the Federal Register (pursuant to 

PHS Act, § 3312(a)(6)(B)(iii) and 42 CFR 

88.17(a)(2)(iii)). In order to publish such 

a proposed addition or a determination 

not to propose a rule, the Administrator 

would first need to find that enough 

scientific evidence is available to 

analyze whether 9/11 exposures are 

associated with the health condition. 

Since the Administrator is unable to 

identify sufficient evidence to conduct 

an analysis of whether to add the health 

condition, the Administrator (pursuant 

to PHS Act, § 3312(a)(6)(B)(iv) and 42 

CFR 88.17(a)(2)(iv)) is publishing a 

determination that he cannot take any of 

the other statutory and regulatory 

actions. 

For the reasons discussed above, the 

request made in Petition 003 to add 

kidney damage/disease to the List of 

WTC-Related Health Conditions is 

denied. 

Dated: March 24, 2014. 

John Howard, 

Administrator, World Trade Center Health 

Program and Director, National Institute for 

Occupational Safety and Health, Centers for 

Disease Control and Prevention, Department 

of Health and Human Services. 

[FR Doc. 2014–06906 Filed 3–28–14; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Part 110 

RIN 0906–AA79 

Countermeasures Injury 

Compensation Program: Pandemic 

Influenza Countermeasures Injury 

Table 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Public Readiness and 

Emergency Preparedness Act (PREP Act) 

directs the Secretary of Health and 

Human Services (the Secretary), to 

establish a Countermeasures Injury 

Compensation Program (the Program) to 

provide ‘‘timely, uniform, and adequate 

compensation’’ to eligible individuals 

who sustain serious physical injuries or 

to certain survivors of individuals who 

die as a direct result of the use or 

administration of covered 

countermeasures identified by the 

Secretary in declarations issued under 

the PREP Act. The Secretary has 

delegated authority to administer the 

Program to the Health Resources and 

Services Administration (HRSA). 

Through this regulation, the Secretary 

proposes a Table for pandemic 

influenza covered countermeasures 

identified by the Secretary in several 

PREP Act declarations. This regulation 

also includes proposed Table time 

intervals for the first symptom or 

manifestation of onset of injury, Table 

injury definitions, and requirements 

which define the terms and conditions 

included on the Table. These are 

considered part of the proposed Table. 

DATES: Written comments must be 

submitted on or before May 30, 2014. 

Subject to consideration of the 

comments received, the Secretary 

intends to publish a final regulation. 

ADDRESSES: You may submit comments 

in one of three ways, as listed below. 


emcdonald on DSK67QTVN1PROD with PROPOSALS