Polychlorinated Dibenzo-p-dioxins and Polychlorinated Dibenzofurans in Bleached Food-Contact Paper Products; Response to Referral for Action by the Environmental Protection Agency and Request for Comment

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. 93N-0352]

Polychlorinated Dibenzo-p-dioxins and Polychlorinated

Dibenzofurans in Bleached Food-Contact Paper Products; Response to

Referral for Action by the Environmental Protection Agency and Request

for Comment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this notice

in response to a notice of referral for action on the use of bleached

food-contact paper products contaminated with polychlorinated dibenzo-

p-dioxins (PCDD's) and polychlorinated dibenzofurans (PCDF's) that was

issued by the Environmental Protection Agency (EPA) under the Toxic

Substances Control Act (TSCA). FDA agrees with EPA's decision to refer

this issue to FDA because, under the Federal Food, Drug, and Cosmetic

Act (the act), FDA has authority to take appropriate action to ensure

that paper and paperboard intended for food-contact use are safe. This

notice sets out the various options that FDA is considering regarding

the issue of PCDD and PCDF contamination of bleached food-contact paper

products and encourages interested persons to submit pertinent data and

other comments on this issue.

DATES: Comments by June 13, 1994.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Edward J. Machuga, Center for Food

Safety and Applied Nutrition (HFS-216), Food and Drug Administration,

200 C St. SW., Washington, DC 20204, 202-254-9511.

SUPPLEMENTARY INFORMATION:

I. Background

PCDD's and PCDF's are formed in trace amounts as byproducts of

certain chemical processes, such as bleaching of paper, incineration,

and manufacturing of certain chlorinated phenols. They are generally

produced as a complex mixture of related compounds or congeners. The

PCDD's and PCDF's are classes of 75 and 135 congeners, respectively,

the most toxic of which is 2,3,7,8-tetrachlorodibenzo-p-dioxin (TCDD).

TCDD has been shown to be a potent animal carcinogen, and EPA has

classified it as a ``probable human carcinogen.''

In order to assess the hazards of mixtures of PCDD's and PCDF's,

scientists have agreed on the use of international toxicity equivalency

factors to express the comparative toxicity of these chemicals as

fractions of the toxicity of TCDD, the most toxic and most studied

congener of the group (Ref. 1). This system expresses the amount of

PCDD's and PCDF's present in terms of TCDD toxic equivalents and

estimates the risk for a mixture as if it were one chemical compound.

Under this system, 2,3,7,8-dibenzofuran (TCDF), the most potent of the

PCDF's, has been assessed a TCDD toxic equivalency of 0.1.

Although the occurrence of low levels of PCDD's and PCDF's in the

environment has been known for years, it has been only recently that

scientists' ability to identify and quantify them has greatly improved.

Based on data obtained in studies carried out in several countries, the

average person is exposed to approximately 1.2 picograms (pg) (10-

12 grams) of TCDD equivalents/kilogram (kg) body weight/day (Ref. 2).

This low level background exposure is mostly dietary, from foods such

as meat, poultry, fish, dairy products, and eggs.

In 1987, results of EPA's National Dioxin Study showed that fish

located downstream from paper mills had higher than expected levels of

TCDD and TCDF. This finding prompted EPA and the American Paper

Institute (API) to conduct a joint study of five paper mills to

discover the source of the TCDD and TCDF contamination. The results of

this study: (1) Confirmed the presence of parts per trillion (ppt)

levels of TCDD and TCDF in pulp and sludge; (2) confirmed parts per

quadrillion (ppq) levels of these substances in wastewater from these

mills; and (3) identified a particular chlorine bleaching process as

the source of the contaminants. Chlorine or chlorine derivatives are

often used as the primary bleaching agent in the process of making

bleached paper products.

These results prompted FDA to begin its own investigation of TCDD

and TCDF contamination of wood pulp and finished paper products that

may contact food and ultimately migrate into the packaged food. Because

the bulk of the TCDD toxic equivalents associated with PCDD and PCDF

contamination of bleached food-contact paper products are attributable

to the presence of TCDD and TCDF, FDA's investigation has focused on

the levels of these two chemicals in bleached food-contact paper

products.

On April 24, 1987, FDA met with representatives of the National

Council of the Paper Industry for Air and Stream Improvement (NCASI) to

discuss protocols for analyzing for residual TCDD and TCDF levels in

bleached wood pulp and in various food-contact paper products. Under

these protocols, newly developed, highly sensitive analytical methods

were used by individual pulp mills to identify those specific processes

that contributed to the formation of TCDD and TCDF so that industry

could identify manufacturing changes that could be made to reduce or

eliminate such contaminants in the finished paper products. FDA also

asked industry representatives to conduct extraction studies to measure

the extent of migration of TCDD and TCDF from uncoated and coated paper

and paperboard into food simulating solvents.

In May of 1988, NCASI released a report entitled ``Assessment of

the Risks Associated with Potential Exposure to Dioxin Through

Consumption of Coffee Brewed Using Bleached Paper Coffee Filters''

(Ref. 3). This study was conducted because given the presence of

residual dioxin contaminants in bleached paper coffee filters and the

high temperature of the water that is passed through the filters, there

appeared to be a high potential for migration of such contaminants into

the brewed coffee. Analysis of 5 different bleached paper coffee

filters found measurable levels of TCDD and TCDF ranging from 2.2 to

6.6 ppt TCDD toxic equivalents in the paper. Migration studies

indicated that 65 to 90 percent of the TCDD equivalents present in the

bleached paper coffee filters could migrate into the coffee, depending

on brewing conditions.

In October of 1988, FDA received the results of a Canadian

Government survey that detected TCDD and TCDF in milk packaged in

bleached paper cartons (Ref. 4). TCDD was found in five of eight

samples of whole milk packaged in coated, bleached paper milk cartons

at concentrations ranging from 0.014 to 0.056 ppt with an average

concentration of 0.038 ppt. TCDF was found in all eight samples at

concentrations ranging from 0.064 to 2.46 ppt (average concentration of

0.98 ppt). Somewhat higher levels were found in cream packaged in

coated, bleached paper milk cartons. Analyses of similar food products

packaged in plastic or glass containers showed at least tenfold lower

levels of TCDD and TCDF, which were most likely a result of background

contamination.

In the spring of 1989, FDA conducted a survey of milk packaged in

bleached paper cartons from five U.S. manufacturers (Ref. 5). TCDD was

found in 4 of 15 samples of whole milk packaged and stored in one-half

pint cartons at refrigerated temperatures for 14 days. The TCDD

concentrations, which ranged from 0.02 to 0.07 ppt, were obtained using

an analytical method that could determine amounts at or above 0.02 ppt.

TCDF was detected in 7 of 15 samples at levels from 0.14 to 0.62 ppt.

The detection limit for TCDF was 0.1 ppt. Because neither TCDD nor TCDF

was detected in bulk or nonpackaged milk collected at the same dairies

before being packaged, the results confirm that these contaminants can

migrate out of the bleached paper carton and into the milk.

Because of FDA's concern about the potential for exposure to TCDD

and TCDF from other bleached paper food-contact articles, FDA requested

that the paper industry provide detailed information that could be used

to determine what other bleached paper articles should be the subject

of detailed migration studies. Based on the results of the industry

survey, FDA also requested, in February 1989, that the paper industry

develop migration data for those paper food-contact articles posing the

greatest potential for exposure to TCDD and TCDF. In response to this

request, the paper industry submitted the results of migration studies

for the following paper articles: (1) Milk cartons (Ref. 6), (2) coffee

filters (Ref. 3), (3) half-and-half (cream) cartons (Ref. 7), (4)

orange juice cartons (Ref. 8), (5) coffee cups (Ref. 9), (6) soup cups

(Ref. 10), (7) dual-ovenable trays (Ref. 11), (8) plates (Ref. 12), and

(9) microwave popcorn bags (Ref. 13).

In 1990, FDA used data from these migration studies, to develop a

quantitative risk assessment for bleached paper food-contact articles

containing TCDD and TCDF residues. The procedures that FDA used in this

evaluation were similar to the methods that the agency has used to

examine the risk associated with the presence of minor amounts of

carcinogenic impurities in various food and color additives (see 49 FR

13018, April 2, 1984). This risk evaluation of carcinogenic

contaminants has two aspects: (1) Assessment of dietary exposure to the

contaminants from the consumption of the additive and (2) extrapolation

of the risk observed in the animal bioassays to the conditions of

probable human exposure.

In addition to the exposure data derived from the industry studies

described above, FDA considered exposure from four other bleached paper

articles that were not subjected to migration testing (bakery cartons,

ice cream cartons, tea bags, and margarine wrappers). An exposure

estimate for each of these articles was derived using an estimated

migration level based on an assumed residue of 17 ppt TCDD equivalents

in the paper article (the average level of TCDD equivalents found to be

in paper pulp in a study of 104 paper mills carried out in 1988 and

1989) (Ref. 14). In its exposure estimates, FDA also considered the

types of food that come into contact with paper articles and the

amounts of these types of food that are ingested daily by consumers.

Based on the results of the migration studies and migration estimates

as well as food consumption information, FDA estimated the daily intake

of TCDD equivalents occurring as a result of migration into food from

bleached paper food-contact articles to be no greater than 0.15 pg/kg

body weight/day (Ref. 14).

In its 1990 risk assessment, the agency used data from a 2-year

chronic toxicity and oncogenicity study carried out by Kociba et al.

(Ref. 15) on TCDD fed to rats to estimate the upper-bound level of

lifetime human risk from exposure to TCDD toxic equivalents resulting

from the use of bleached food-contact paper products. The results of

the bioassay on TCDD showed that the material was carcinogenic for rats

under the conditions of the study. The test material caused

significantly increased incidences of hepatocellular carcinomas and

adenomas as well as squamous cell carcinomas of the lung, hard palate,

nasal turbinates, and tongue. FDA's toxicologists further concluded

that given the paucity of TCDD bioassay data, the Kociba et al.

bioassay provided the appropriate basis on which to calculate an

estimate of the upper-bound level of lifetime carcinogenic risk from

exposure to TCDD toxic equivalents stemming from the use of bleached

food-contact paper products.

The agency used a linear-at-low-dose extrapolation from the doses

used in the Kociba et al. bioassay to the very low levels of TCDD toxic

equivalents encountered under actual conditions of use of bleached

food-contact paper products. This procedure is not likely to

underestimate the actual risk from very low doses and may, in fact,

exaggerate it because the extrapolation models used are designed to

estimate the maximum risk consistent with the data. Using a linear-at-

low-dose extrapolation method and the tumor incidence data based on the

original classification of tumors found in the Kociba et al. study, the

FDA estimated a carcinogenic unit risk of 16 x 10-6 for an intake

of 1 pg/kg body weight/day of TCDD toxic equivalents. Using this

carcinogenic risk for TCDD and a daily dietary exposure of 0.15 pg of

TCDD equivalents/kg body weight/day (based on data obtained from 1988

to 1990), FDA's 1990 risk assessment estimated that the upper-bound

limit of individual lifetime risk from TCDD toxic equivalents that

result from the use of bleached food-contact paper products at that

time would be 2.5 x 10-6 or 2.5 in 1 million (Ref. 16). Because of

the conservative assumptions used to obtain the exposure estimate,

actual lifetime-averaged individual exposure to TCDD toxic equivalents

is expected to be substantially less than the estimated daily intake,

and therefore, the actual risk would be less than the calculated upper-

bound limit of risk.

This risk was considered low by both FDA and EPA (December 26,

1990, 55 FR 53047). However, because the then current levels of PCDD's

and PCDF's (mostly TCDD and TCDF) in bleached white paper were capable

of being reduced by the pulp and paper industry through changes in

manufacturing procedures, EPA considered the risk associated with

PCDD's and PCDF's in food-contact paper products to be ``unreasonable''

in accordance with section 9(a) of TSCA (55 FR 53047).

EPA has the authority to require the reduction of ``unreasonable''

risk associated with bleached paper products under section 6(a) of

TSCA, which states that EPA may prohibit or limit production of a

chemical substance that presents an ``unreasonable'' risk to human

health or the environment. However, under section 9(a) of TSCA, if EPA

determines that the risk can be reduced by an action taken by another

agency, it may refer such action to the other agency.

In the notice published in the Federal Register of December 26,

1990, EPA announced that under section 9(a) of TSCA, it was referring

action to FDA on the use of food-contact paper products contaminated

with PCDD's and PCDF's. Specifically, EPA has requested that FDA do the

following: (1) Assess the risk associated with PCDD and PCDF

contaminated bleached food-contact paper products; (2) determine if

this risk may be prevented or reduced by action taken under its own

authority, and (3) if so, initiate the appropriate regulatory action.

II. FDA's Response to EPA's Referral for Action

FDA agrees with EPA's decision to refer the use of bleached food-

contact paper products that may be contaminated with PCDD's and PCDF's

(mostly TCDD and TCDF) to FDA because under the act, FDA has the

authority to take appropriate regulatory action to ensure that bleached

paper and paperboard intended for food-contact use are safe. At the

time that FDA received this referral, the agency considered whether

immediate regulatory action was necessary to ensure the safe use of

bleached food-contact paper products. As stated above, FDA's risk

assessment in 1990 of exposure to TCDD and TCDF, resulting from the use

of those types of bleached food-contact paper products that have the

greatest potential for migration of these substances into food,

produced an estimated upper-bound worst-case lifetime risk of 2.5 in 1

million. However, the estimated daily dietary intake used in this risk

assessment was based on data obtained from 1988 to 1990. By the time

FDA received the referral, many of the paper mills that make bleached

paper had made or were in the process of making manufacturing changes

to reduce or eliminate residual TCDD and TCDF levels in bleached paper

intended for use in contact with food. Therefore, rather than

expressing the risk in terms of an average 70-year lifespan, FDA

believed that it was more appropriate to view the carcinogenic risk in

terms of yearly exposure during the limited time needed by the paper

industry to complete the manufacturing changes necessary to reduce the

levels of such contaminants in paper products.

An upper-bound worst-case lifetime risk of 2.5 in 1 million

corresponds to less than 0.04 in 1 million for each year of exposure.

Based on this level of risk per year of exposure, FDA felt at the time

that it received the referral that the continued use of bleached paper

and paperboard in contact with food was safe during the time needed by

FDA to complete its evaluation of TCDD and TCDF contamination of

bleached food-contact paper products. FDA also felt at that time that

it should conduct a new lifetime risk assessment in light of the

changes in the manufacturing of bleached food-contact paper products

that had occurred.

Given the cooperation that FDA had received from the paper

industry, FDA decided that it was appropriate to explore voluntary

avenues for reducing exposure to PCDD's and PCDF's from the use of

bleached paper and paperboard. At a meeting held on November 16, 1990,

API advised FDA that 100 percent of the U.S. manufacturers of bleached

paper for food-contact applications were participating in a voluntary

program to reduce TCDD levels in all types of food-contact paper

products to 2 ppt or less. In a letter of March 7, 1991, API submitted

data to FDA showing that all bleached paper milk cartons manufactured

since July 30, 1990, had residual TCDD levels of 2 ppt or less (Ref.

17). API also informed FDA that 93 percent of bleached food-contact

paper and paperboard met the 2 ppt or less TCDD standard as of December

31, 1991, and that 98 percent of these products were expected to meet

this standard by the end of 1992 (Ref. 18).

The American Forest and Paper Association (AFPA), formed by the

recent merger of API with other forest related associations, has

submitted to FDA the results of an industry-wide survey conducted

during the first quarter of 1993 to determine the degree of compliance

with the voluntary specification of 2 ppt or less of residual TCDD in

bleached food-contact paper products (Ref. 19). These results show that

all of the U.S. manufacturers responding to the survey have implemented

standard operating procedures that result in bleached food-contact

paper products that meet the voluntary specification of 2 ppt or less

of TCDD. Out of 249 tests conducted on samples of either bleached pulp,

paper, or paperboard, only 3 samples had detectable levels of TCDD that

were above 2 ppt (i.e., 2.1 ppt, 2.2 ppt, and 2.6 ppt). The levels of

TCDD that were found to be above 2 ppt in the survey are likely to be

the result of normal variability associated with both the methodology

used to analyze for the TCDD and the manufacturing procedures used to

produce the bleached paper products. Moreover, although the paper

industry's voluntary program specifically deals with residual levels of

TCDD in bleached food-contact paper products, industry data have shown

that the manufacturing changes that have resulted in the significant

reduction of TCDD in such products also have resulted in a

corresponding decrease in TCDF (Ref. 17).

In 1992, FDA also conducted its own analysis of uncoated bleached

paper destined for use in milk cartons (Ref. 20) to confirm whether it

meets the voluntary specification of 2 ppt or less of TCDD. These tests

used analytical methodology developed by FDA's Chicago District

Laboratory (Ref. 21). FDA collected samples in late 1991 and early 1992

from five U.S. manufacturers that produce over 90 percent of the

domestic paper stock used for milk cartons. Paper stock from two of the

manufacturers contained very low levels of TCDD (1.4 and 1.5 ppt,

respectively) and TCDF (4.0 and 4.7 ppt, respectively). Residual levels

of TCDD and TCDF could not be detected in the paper stock from the

other three manufacturers using an analytical method sensitive to 1 ppt

for TCDD and 2 ppt for TCDF. These results support the paper industry's

claim that the bleached paper used to manufacture milk cartons is in

compliance with a voluntary specification of 2 ppt for TCDD.

FDA has also recently completed an analysis of milk samples

contained in cartons manufactured using bleached paper (Ref. 22).

Fifteen milk samples were collected in late 1991 and early 1992 from

dairies that use bleached paper from the five major U.S. manufacturers.

None of the samples contained detectable levels of TCDD and TCDF using

analytical methodologies with detection limits in the 2 to 10 ppq

range.

In addition, FDA has developed a new risk assessment to determine

what the current upper-bound lifetime cancer risk is from exposure to

TCDD toxic equivalents resulting from the use of bleached paper and

paperboard products meeting the paper industry's voluntary

specification of 2 ppt or less of TCDD. In the absence of migration

data for bleached paper products containing such low levels of TCDD

(i.e., 2 ppt or less), FDA assumed that the percent migration of TCDD

from a specific type of food-contact article meeting the voluntary 2

ppt TCDD specification would be similar to the percent migration

observed in earlier studies (Ref. 14). Because the percent migration

decreases as the level of the migrant in the food-contact article

decreases, this approach is not likely to underestimate migration

levels. Using the above assumption and assuming that all bleached food-

contact paper products contain residual levels of TCDD low enough to

meet a 2 ppt TCDD specification, FDA estimates that the upper-bound

daily dietary intake of TCDD toxic equivalents is no greater than 1.8

pg/person/day (0.03 pg TCDD equivalents/kg body weight/day for a 60-kg

person) (Ref. 23). FDA used this exposure estimate to determine the

current upper-bound lifetime cancer risk from TCDD toxic equivalents

resulting from the use of bleached food-contact paper products assuming

that virtually all of such products meet a 2 ppt TCDD specification.

The carcinogenic unit risk used by FDA in its 1990 risk assessment

was based on tumor incidence data from the Kociba et al. study (Ref.

15). Following FDA's 1990 risk assessment, however, a group of

pathologists, called the Pathology Working Group (PWG), reanalyzed the

slides of the liver tumors observed in the 1978 Kociba rat bioassay

using the National Toxicological Program's 1986 classification system

for liver tumors (Ref. 24). FDA has reviewed the results of this

reanalysis and agrees with the classification of the tumors made by

PWG. Using the results of this revised reading of the Kociba study

slides, FDA estimates a carcinogenic unit risk of 9 x 10-6 for an

intake of 1 pg TCDD equivalents/kg body weight/day. Using this

carcinogenic unit risk and an upper-bound daily dietary exposure

estimate of 0.03 pg TCDD equivalents/kg body weight/day, FDA estimates

that the upper-bound limit of individual lifetime cancer risk from TCDD

toxic equivalents would be 3 x 10-7 for the use of bleached food-

contact paper products meeting a 2 ppt TCDD specification (Ref. 25).

The agency obtained this 3 x 10-7 risk estimate by assuming

that the lifetime cancer risk from TCDD would be equal in mammalian

species, such as in man and in rodents when the daily feeding doses are

in proportion to body weight raised to the first power (i.e.,

equivalence based on feeding dose/body weight/day). This approach is

the one that FDA has traditionally used in extrapolating results of

rodent carcinogen bioassays to man. However, in the Federal Register of

June 5, 1992 (57 FR 24152), EPA, FDA, and the Consumer Product Safety

Commission published a draft report proposing to establish a common

default methodology for determining equivalence in carcinogenic unit

risks between mammalian species. If adopted, this unified default

approach will be used in those cases where existing agent-specific data

are insufficient to make a case-by-case determination. Based on an

analysis of empirical and theoretical aspects of the cross-species

dose-scaling question, the proposed unified default approach assumes

that the lifetime cancer risk from the intake of a carcinogenic

substance is equal in different mammalian species when the daily

feeding doses are in proportion to body weight raised to the 3/4 power

(i.e., equivalence based on feeding dose/body weight3/4/day).

Although this proposed unified default methodology has not been

adopted by the three agencies, FDA has used it to calculate a second

estimate of the upper-bound lifetime cancer risk from TCDD exposure if

all bleached food-contact paper products meet the paper industry's

voluntary specification of 2 ppt for residual levels of TCDD. Using a

scaling factor based on equivalence of pg/kg3/4/day to extrapolate

the tumor incidence data obtained from the revised reading of the

Kociba rodent bioassay slides to man, FDA estimates a carcinogenic unit

risk of 30 x 10-6 (pg TCDD equivalents/kg body weight/day)-1.

Using this carcinogenic unit risk for TCDD and an upper-bound daily

dietary exposure estimate of 0.03 pg TCDD equivalents/kg body weight/

day, FDA estimates that the upper-bound limit of individual lifetime

risk from TCDD toxic equivalents would be 9 x 10-7 for the use of

bleached food-contact paper products meeting a 2 ppt TCDD specification

(Ref. 25).

Both of the above upper-bound lifetime risk estimates (3 x 10-

7 and 9 x 10-7), obtained using cross-species scaling factors

based on equivalence of pg/kg/day and pg/kg3/4/day, respectively,

would generally be viewed as very low. However, until the proposed

unified default methodology has been formally adopted, FDA will use the

3 x 10-7 risk as the best estimate of what the upper-bound

lifetime risk from TCDD toxic equivalents would be when all bleached

food-contact paper products meet the paper industry's voluntary

specification of 2 ppt for residual levels of TCDD.

On the basis of: (1) FDA's 1990 risk assessment which showed an

upper-bound lifetime cancer risk of less than 0.04 in 1 million for

each year of exposure based on residual levels of TCDD and TCDF in

bleached food-contact paper products manufactured between 1988 and

1990; (2) the significant progress made by the paper industry in

reducing residual TCDD and TCDF in bleached paper products (AFPA has

submitted to FDA the results of an industry wide survey conducted

during the first quarter of 1993 showing that U.S. manufacturers have

implemented standard operating procedures that result in bleached food

contact paper products that meet the voluntary specification for 2 ppt

or less of TCDD); and (3) FDA's new risk assessment that the upper-

bound limit of individual lifetime risk from TCDD toxic equivalents is

3 x 10-7 if all bleached food-contact paper products in fact meet

the paper industry's voluntary specification of 2 ppt for residual

levels of TCDD, FDA tentatively concludes that the continued use of

bleached paper and paperboard in contact with food is safe during the

time that has been, and will be, needed by FDA to complete its

evaluation.

FDA will continue to monitor the paper industry's progress in

reducing TCDD and TCDF contamination of bleached food-contact paper

products manufactured in the United States. The agency will also

consider monitoring residual levels of TCDD and TCDF in bleached food-

contact paper and paperboard imported into this country as well as in

the bleached paper and paperboard packaging of imported foods.

Information currently available to the agency shows that imported

bleached food-contact paper products comprise only 3 percent of such

products used in the United States.

Data obtained in a recent human epidemiological study involving

workers exposed to low levels of TCDD may also provide an additional

approach to assessing the carcinogenic risk to humans (Ref. 26). FDA

plans to review these data and determine if they are suitable for risk

assessment purposes. If suitable, the carcinogenic potency for TCDD in

humans obtained using these data would provide an alternative to the

current risk assessment approach which requires the extrapolation from

animal data. FDA will also consider any other data that become

available while it completes its review.

The results of FDA's monitoring of the residual levels of TCDD and

TCDF in bleached food-contact paper products together with data and

comments received in response to this notice will be used by FDA to

determine if any regulatory action is needed to ensure the safe use of

such products. If FDA determines that regulatory action is necessary,

one possible course of action would be to amend the food additive

regulations to establish a specification for maximum allowable levels

of residual TCDD and TCDF in food-contact paper products in accordance

with section 409 of the act. Using this approach, bleached paper that

is intended for use in food-contact articles, and that is expected to

contain TCDD and TCDF that will migrate into food, would be regarded as

a food additive as defined in section 201(s) of the act and be subject

to premarket approval under section 409 of the act (21 U.S.C. 348). A

substance, such as bleached paper, that has not been shown to cause

cancer, but that contains a carcinogenic impurity such as TCDD, is

evaluated under the general safety clause of the statute using risk

assessment procedures to determine whether there is a reasonable

certainty that no harm will result from its use (Scott v. FDA, 728 F.2d

322 (6th Cir. 1984)). The risk assessment procedures could be used by

FDA to determine the residual level of TCDD and TCDF in bleached food-

contact paper at which there is reasonable certainty that no harm will

result from the use of the bleached paper. FDA would institute

rulemaking to amend its food additive regulations to authorize the

food-contact use of bleached paper the contain such levels of TCDD and

TCDF.

A second course of action would be for FDA not to proceed with

rulemaking and to take action against TCDD and TCDF in food-contact

paper products on a case-by-case basis. To clarify the levels that

would be of concern to FDA, the agency could publish an action level

for residual TCDD and TCDF in bleached food-contact paper products. FDA

relies on action levels to provide guidance on the level of added

poisonous or deleterious substances that may render food adulterated.

The agency has found action levels to be particularly useful in cases,

such as the TCDD and TCDF contamination of bleached paper products,

where the technology and science associated with an issue continue to

change. Although the act is mute on the use of action levels, court

decisions on this regulatory approach (Community Nutrition Institute v.

Young, 818 F.2d 943,946 (D.C. Cir. 1987)) have supported their use by

FDA as long as it is made clear that such levels are not legally

binding on either industry or the agency.

FDA requests comments on other possible regulatory approaches that

it could use to ensure that any residual amounts of TCDD and TCDF in

bleached food-contact paper products will be safe.

III. Request for Comments

FDA invites public comment on all aspects of this notice concerning

residual levels of TCDD and TCDF in bleached food-contact paper

products. The preamble to any proposal on this issue will include

consideration of comments received in response to this notice.

Interested persons may, on or before June 13, 1994, submit to the

Dockets Management Branch (address above) written comments regarding

this notice. Trade secret and commercial confidential information

should be submitted to the contact person identified above. Trade

secret and commercial confidential information will be protected from

public disclosure in accordance with 21 CFR part 20. Two copies of any

comments are to be submitted, except that individuals may submit one

copy. Comments are to be identified with the docket number found in

brackets in the heading of this document. Received comments may be seen

in the office above between 9 a.m. and 4 p.m., Monday through Friday.

IV. References

The following references have been placed on display in the Dockets

Management Branch (address above) and may be seen by interested persons

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

1. ``Pilot Study on International Information Exchange on

Dioxins and Related Compounds,'' North Atlantic Treaty Organization,

report no. 178, December 1988.

2. ``Assessment of Health Risks in Infants Associated with

Exposure to PCBs, PCDDs and PCDFs in Breast Milk,'' report on a

World Health Organization working group, pp. 1-7, 1988.

3. ``Assessment of the Risks Associated with Potential Exposure

to Dioxin Through the Consumption of Coffee Brewed Using Bleached

Paper Coffee Filters,'' NCASI Technical Bulletin, No. 546, 1988.

4. Letter from EPA to FDA, containing Canadian study of dioxin

in packaged milk, September 27, 1988.

5. ``Survey of Dioxin-Furan in Milk Packaged in Paper Cartons,''

FDA FY 89 field assignment, August 1989.

6. ``NCASI Milk Carton Migration Study,'' first progress report,

August 1989.

7. ``NCASI Milk Carton Migration Study of Half and Half,''

January 1990.

8. ``NCASI Orange Juice Carton Migration Study,'' interim

report, December 1989.

9. ``NCASI Hot Beverage Paper Cup Coffee Exposure Scenario

Migration Study,'' interim report, October 1989.

10. ``NCASI Hot Beverage Paper Cup Chicken Broth Exposure

Scenario Migration Study,'' interim report, November 1989.

11. ``NCASI Dual Ovenable Tray Migration Study,'' interim

report, November 1989.

12. ``NCASI Plates/Trays/Dishes Migration Study,'' interim

report, November 1989.

13. Letter dated March 6, 1990, from NCASI, containing microwave

popcorn bag migration study.

14. Memorandum dated June 13, 1990, from Food and Color

Additives Review Section, ``Exposure to Dioxin Congeners from Foods

Contacting Bleached Paper Products.''

15. Kociba, R. J., et al., ``Results of a Two-Year Chronic

Toxicity and Oncogenicity Study of 2,3,7,8-Tetrachlorodibenzo-p-

Dioxin in Rats,'' Toxicology and Applied Pharmacology, 46:279-303,

1978.

16. Report of the Quantitative Risk Assessment Committee,

``Carcinogenic Risk Assessment for Dioxins and Furans in Foods

Contacting Bleached Paper Products,'' April 20, 1990.

17. Letter dated March 7, 1991, from the American Paper

Institute, concerning TCDD levels in bleached paper and paperboard

as of December 31, 1990.

18. Letter dated April 17, 1992, from the American Paper

Institute, concerning TCDD levels in bleached paper and paperboard

as of December 31, 1991.

19. Letter dated July 30, 1993, from the American Forest and

Paper Association, concerning TCDD levels in bleached pulp, paper

and paperboard as of the First Quarter of 1993.

20. Memorandum dated November 2, 1992, from Methods Research

Branch, ``TCDD and TCDF Residues in Bleached Paper Stock used in

Milk Cartons.''

21. ``The Determination of 2,3,7,8-tetrachlorodibenzo-p-dioxin

and 2,3,7,8-tetrachlorodibenzofuran in Paper Products,'' Laboratory

Information Bulletin, FDA's Chicago District Laboratory, May 1992.

22. Memorandum dated February 25, 1993, from Methods Research

Branch, HFS-336, ``TCDD and TCDF Residues in Milk Packaged in

Bleached Paper Cartons.''

23. Memorandum dated November 14, 1991, from Food and Color

Additives Review Section, ``Exposure to Dioxin Congeners from Foods

Contacting Bleached Paper Products With Dioxin Levels Not Exceeding

2 ppt.''

24. ``2,3,7,8-Tetrachlorodibenzo-p-dioxin in Sprague-Dawley

Rats,'' Pathco Inc., March 13, 1990.

25. Report of the Quantitative Risk Assessment Committee,

``Upper-Bound Lifetime Carcinogenic Risks From Exposure to Dioxin

Congeners From Foods Contacting Bleached Paper Products With Dioxin

Levels Not Exceeding 2 ppt,'' January 27, 1993.

26. Fingerhut, M., et al., ``Cancer Mortality in Workers Exposed

to 2,3,7,8-Tetrachlorodibenzo-p-dioxin,'' The New England Journal of

Medicine, vol. 324, pp. 212-218, 1991.

Dated: February 2, 1994.

Michael R. Taylor,

Deputy Commissioner for Policy.

[FR Doc. 94-8698 Filed 4-11-94; 8:45 am]

BILLING CODE 4160-01-F