Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Notices 47593 

filing notice for a food additive petition 

filed by the National Fisheries Institute, 

to provide for the safe use of ionizing 

radiation for control of foodborne 

pathogens in crustaceans and processed 

crustaceans. 

FOR FURTHER INFORMATION CONTACT: 

Lane A. Highbarger, Center for Food 

Safety and Applied Nutrition (HFS– 

255), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 301–436–1204. 

SUPPLEMENTARY INFORMATION: Under the 

Federal Food, Drug, and Cosmetic Act 

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))), a 

notice was published in the Federal 

Register of February 6, 2001 (66 FR 

9086) announcing that a food additive 

petition (FAP 1M4727) had been filed 

by the National Fisheries Institute, 7918 

Jones Branch Dr., McLean, VA 22102, 

proposing that the food additive 

regulations in part 179 Irradiation in the 

Production, Processing and Handling of 

Food (21 CFR part 179) be amended to 

provide for the safe use of ionizing 

radiation for control of foodborne 

pathogens in raw-, frozen-, cooked-, 

partially cooked-, shelled-, or dried 

crustaceans, or cooked- or ready-to-cook 

crustaceans processed with batter, 

breading, spices, or small amounts of 

other food ingredients. 

Subsequent to the publication of the 

filing notice, the National Fisheries 

Institute amended the scope of their 

petition so as to exclude the use of 

breading or batter. FDA received a letter 

from the National Fisheries Institute, 

dated July 16, 2009, asking FDA to 

modify the scope of the petition so that 

breading and batter are not included. 

Therefore, FDA is amending the filing 

notice of February 6, 2001, to state that 

the National Fisheries Institute is 

proposing that the food additive 

regulations in part 179 be amended to 

provide for the use of ionizing radiation 

for the control of foodborne pathogens 

in raw-, frozen-, cooked-, partially 

cooked-, shelled-, or dried-crustaceans 

or cooked- or ready-to-cook crustaceans 

processed with spices or small amounts 

of other food ingredients. 

The agency has determined under 21 

CFR 25.32(i) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

Dated: September 4, 2009. 

Laura M. Tarantino, 

Director, Office of Food Safety, Center for 

Food Safety and Applied Nutrition. 

[FR Doc. E9–22008 Filed 9–15–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket Number NIOSH–057] 

Request for Information on 1- 

Bromopropane 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of public comment 

period. 

SUMMARY: The National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC) intends to 

evaluate the scientific data on the 

brominated organic solvent, 1- 

Bromopropane (1–BP, CAS # 106–94–5, 

also known as n-propyl bromide), and 

develop appropriate communication 

documents, such as a Current 

Intelligence Bulletin, Criteria Document 

and/or other informational products, 

and establish a Recommended Exposure 

Limit (REL) for 1–BP. NIOSH is 

requesting information on the following: 

(1) published and unpublished reports 

and findings from in vitro and in vivo 

toxicity studies with 1–BP, (2) 

information on possible health effects 

observed in workers exposed to 1–BP, 

(3) information on workplaces and 

products in which 1–BP can be found, 

(4) description of work tasks and 

scenarios with a potential for exposure 

to 1–BP, (5) workplace exposure data, 

and (6) information on control measures 

(e.g., engineering controls, work 

practices, personal protective 

equipment) that are being used in 

workplaces where potential exposures 

to 1–BP occur. 

Public Comment Period: Comments 

must be received by December 14, 2009. 

ADDRESSES: You may submit comments, 

identified by docket number NIOSH– 

057, by any of the following methods: 

• Mail: NIOSH Docket Office, Robert 

A. Taft Laboratories, MS–C34, 4676 

Columbia Parkway, Cincinnati, OH 

45226. 

• Facsimile: (513) 533–8285. 

• E-mail: nioshdocket@cdc.gov. 

All information received in response 

to this notice will be available for public 

examination and copying at the NIOSH 

Docket Office, 4676 Columbia Parkway, 

Cincinnati, Ohio 45226. A complete 

electronic docket containing all 

comments submitted will be available 

on the NIOSH Web page at http:// 

www.cdc.gov/niosh/docket, and 

comments will be available in writing 

by request. NIOSH includes all 

comments received without change in 

the docket, including any personal 

information provided. 

FOR FURTHER INFORMATION CONTACT: G. 

Scott Dotson, PhD, NIOSH, Robert A 

Taft Laboratories, MS–C32, 4676 

Columbia Parkway, Cincinnati, OH 

45226, telephone (513) 533–8540. 

SUPPLEMENTARY INFORMATION: 1–BP is a 

brominated organic solvent that has 

received increased global attention in 

recent years as a potential alternative for 

ozone depleting substances and other 

compounds with known adverse health 

effects, such as chlorofluorocarbons 

(CFC), hydrochlorofluorocarbons 

(HCFC), and methylene chloroform. 1– 

BP is used in multiple industrial 

processes including vapor and 

immersion degreasing operations, and 

as a solvent in industries using aerosolapplied adhesives; 1–BP is also 

proposed as a replacement solvent for 

perchloroethylene in the dry-cleaning 

sector. The National Toxicology 

Program (NTP) estimated that 

approximately 8.2 million pounds (lbs) 

of 1–BP were used in the United States 

(U.S.) in 2002. Estimates of the number 

of workers exposed to 1–BP are 

unavailable due to limited exposure 

data and its relatively recent 

introduction into domestic commerce. 

The toxic nature of 1–BP is not fully 

understood. Recently published case 

reports describe possible adverse health 

effects, including neurotoxicity, 

following occupational exposures to 1– 

BP. The findings of animal toxicity 

studies in rats and mice indicate that 1– 

BP may be a reproductive and 

developmental toxicant, in addition a 

neurotoxicant. No occupational 

exposure limits for 1–BP have been 

established by NIOSH or the 

Occupational Safety and Health 

Administration (OSHA). 

NIOSH seeks to obtain materials, 

including published and unpublished 

reports and research findings, to 

evaluate the possible health risks of 

occupational exposure to 1–BP. 

Examples of requested information 

include, but are not limited to, the 

following: 

(1) Identification of industries or 

occupations in which exposures to 1–BP 

may occur. 

(2) Trends in the production and use 

of 1–BP and 1–BP containing 

compounds. 

(3) Description of work tasks and 

scenarios with a potential for exposure 

to 1–BP. 


srobinson on DSKHWCL6B1PROD with NOTICES
47594 Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Notices 

(4) Workplace exposure measurement 

data in various types of industries and 

jobs. 

(5) Case reports or other health 

information demonstrating potential 

health effects in workers exposed to 1– 

BP. 

(6) Research findings from in vitro and 

in vivo toxicity studies. 

(7) Information on controls (e.g., 

engineering controls, work practices, 

PPE) including costs and effectiveness 

of control measures being taken to 

minimize worker exposure to 1–BP. 

(8) Educational materials for worker 

safety and training on the safe handling 

of 1–BP. 

(9) Data pertaining to the feasibility of 

establishing a more protective REL for 

1–BP including projected costs of 

control strategies considered. 

(10) Names of substitute chemicals or 

processes being used in place of 1–BP 

and type of work tasks. 

Dated: September 9, 2009. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. E9–22297 Filed 9–15–09; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket Number NIOSH–150] 

Request for Information on Alternative 

Duty: Temporary Reassignment for 

Health Care Workers Who Work With 

Hazardous Drugs 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of public comment 

period. 

SUMMARY: NIOSH intends to publish a 

Current Intelligence Bulletin (CIB) on 

alternative duty and other forms of 

administrative controls for health care 

workers who work with hazardous 

drugs and are trying to conceive, are 

pregnant, and/or are breast feeding. 

Alternative duty involves transferring 

the worker to a similar position, but one 

in which they would not be required to 

handle hazardous drugs. 

Exposure to certain hazardous drugs 

can affect reproduction and have 

adverse health effects on the developing 

fetus. Some hazardous drugs are known 

to be present in the breast milk of 

patients treated with them [Briggs et al. 

2005]. NIOSH plans to develop 

recommendations in this CIB on 

alternative duty and administrative 

controls that will protect the workers 

and their offspring from the potential 

adverse reproductive effects of 

hazardous drugs. 

NIOSH is requesting (1) comments 

and information relevant to the 

potential reproductive effects of 

hazardous drugs, (2) reports or other 

data that investigate possible adverse 

reproductive effects in workers exposed 

to hazardous drugs, and (3) information 

pertaining to alternative duty policies 

and administrative controls for workers, 

particularly couples trying to conceive 

and women who are pregnant and 

breastfeeding, and who are exposed to 

hazardous drugs in health care and 

other industries. 

Public Comment Period: Comments 

must be received within 60 calendar 

days of publication in the Federal 

Register. 

ADDRESSES: You may submit comments, 

identified by docket number NIOSH– 

150, by any of the following methods: 

• Mail: NIOSH Docket Office, Robert 

A. Taft Laboratories, MS–C34, 4676 

Columbia Parkway, Cincinnati, OH 

45226. 

• Facsimile: (513) 533–8285. 

• E-mail: nioshdocket@cdc.gov. 

All information received in response 

to this notice will be available for public 

examination and copying at the NIOSH 

Docket Office, Room 111, 4676 

Columbia Parkway, Cincinnati, Ohio 

45226. A complete electronic docket 

containing all comments submitted will 

be available on the NIOSH Web page at 

http://www.cdc.gov/niosh/docket, and 

comments will be available in writing 

by request. NIOSH includes all 

comments received without change in 

the docket, including any personal 

information provided. 

FOR FURTHER INFORMATION CONTACT: 

Thomas Connor, PhD, NIOSH Robert A. 

Taft Laboratories, MS–C23, 4676 

Columbia Parkway, Cincinnati, OH 

45226, (513) 533–8399, e-mail 

tmc6@cdc.gov. 

SUPPLEMENTARY INFORMATION: Drugs 

have a successful history in treating 

illnesses and injuries, and are 

responsible for many of our medical 

advances over the past century. 

However, virtually all drugs can have 

side effects associated with patient use 

[NIOSH 2004]. In addition to risks in 

patients, workers who handle them are 

at risk of suffering these effects. In 

addition, it is known that exposures to 

even very small concentrations of 

certain drugs may be hazardous for 

workers who handle them or work near 

them. Occupational exposures to 

hazardous drugs can lead to adverse 

reproductive events [NIOSH 2004, 

Dranitsaris et al. 2005]. 

The term ‘‘hazardous drugs’’ was first 

used by the American Society of 

Hospital Pharmacists (ASHP) in 1990 

and recent updates to their guidelines 

[ASHP 2006] and is currently used by 

NIOSH [2004] and the Occupational 

Safety and Health Administration 

(OSHA) [OSHA 1999]. Drugs are 

classified as hazardous if studies in 

animals or humans indicate that 

exposures to them have a potential for 

causing cancer, genotoxicity, 

developmental or reproductive toxicity, 

or harm to organs. Many drugs with a 

hazardous classification are used to treat 

illnesses such as cancer (antineoplastic 

drugs) or HIV infection (antiviral drugs). 

See Appendix A of the NIOSH Alert 

[NIOSH 2004] for examples of 

hazardous drugs and a full discussion of 

criteria used to define and classify them 

as hazardous. 

The numbers and types of work 

environments containing antineoplastic 

drugs are expanding as these agents are 

used increasingly for nonmalignant 

rheumatologic and immunologic 

diseases [NIOSH 2004]. 

When exposed to hazardous drugs, 

health care workers face several health 

risks, including reproductive risks. A 

reproductive hazard affects the 

reproductive function of women or men 

or the ability of couples to have healthy 

children [HSE 2003]. Some chemicals, 

including many hazardous drugs, are 

considered reproductive hazards 

because studies in humans or animals 

show that exposure to them may affect 

fertility, pregnancy outcome, or cause 

birth defects. 

Evidence shows that these drugs have 

caused adverse reproductive outcomes 

in health care workers. For example, 

nurses and pharmacists exposed to 

hazardous drugs at their worksite 

reported an increase in adverse 

reproductive events including 

spontaneous abortions, stillbirths, and 

congenital malformations when 

compared with unexposed health care 

workers [NIOSH 2004]. In addition, 

some drugs may negatively affect germ 

cell (sperm and egg) development 

[McInnes and Schilsky 1996]. 

In the United States, an estimated 8 

million health care workers [BLS 2007] 

are potentially exposed to hazardous 

drugs at their worksites and may be 

vulnerable to reproductive risks. These 

workers include pharmacists and 

pharmacy technicians, nursing 

personnel, physicians, operating room 


srobinson on DSKHWCL6B1PROD with NOTICES