[Federal Register Volume 59, Number 70 (Tuesday, April 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8698]


[[Page Unknown]]

[Federal Register: April 12, 1994]


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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