[Federal Register Volume 59, Number 24 (Friday, February 4, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-2472]


[[Page Unknown]]

[Federal Register: February 4, 1994]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 73, 74, 168, 172, 173, 182, and 184

[Docket No. 93N-0348]

 

Lead in Food and Color Additives and GRAS Ingredients; Request 
for Data

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
intends to take several related actions to reduce the amount of lead in 
food from the use of food and color additives and food ingredients 
whose use is generally recognized as safe (GRAS). This action is part 
of its ongoing efforts to reduce the levels of lead in food. In this 
document, the agency is identifying the lead levels that it intends to 
propose as new, lower lead specifications for the most heavily used 
food and color additives and GRAS ingredients. Before proposing these 
specifications, however, the agency is requesting information on 
whether these levels are feasible, and, if they are not, information on 
why higher levels will not endanger the public health, and on what 
levels are feasible. The agency is requesting specific data and 
information on the lead levels and the methods for detecting lead in 
these substances. Additionally, the agency is requesting information on 
the economic and environmental effects of lowering the lead levels.

DATES: Comments and information provided by May 5, 1994.

ADDRESSES: Submit written comments and information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Helen R. Thorsheim, 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: In this advance notice of proposed 
rulemaking (ANPRM), the agency is announcing its intention to decrease 
the amount of lead derived from food and color additives and GRAS food 
ingredients in the diet through several actions. These actions are 
prompted by the results of recent studies showing that deleterious 
health effects are caused by much lower levels of lead than previous 
results indicated, especially in fetuses, infants, and young children. 
Also, the development of more sensitive analytical methods has made it 
possible to detect lower lead levels in food ingredients.
    This ANPRM has four purposes: (1) To discuss the toxic effects of 
lead and to describe the multiple sources of lead in the human 
environment; (2) to summarize actions that FDA and other Federal 
agencies have taken to reduce lead exposures; (3) to discuss available 
data and potential exposures to lead from the consumption of food, 
including food and color additives and GRAS ingredients used in food; 
and (4) to describe the need for new petitions for moderate and high 
consumption food and color additives and GRAS ingredients to include 
specific information on the levels of lead in these substances. This 
information is necessary to assess the substance's contribution of lead 
to the diet, and, therefore, whether it is safe for its intended use.
    The agency intends to propose new, lower lead specifications for 
moderate and high consumption food ingredients that either are the 
subject of premarket review or are currently in use, to ensure that the 
amount of lead contributed to the diet from the use of these food and 
color additives and GRAS ingredients is as low as feasible. The agency 
intends to propose adopting specifications of 0.5 part per million 
(ppm) for moderate consumption food ingredients and 0.1 ppm for high 
consumption food ingredients, unless information is submitted to show 
that such levels are not feasible and that higher specifications will 
not endanger the public health. Finally, the ANPRM requests specific 
information on the lead levels and the methods used to detect lead in 
the moderate and high consumption substances identified and on the 
economic and environmental effects of lowering the lead levels in these 
food and color additives and GRAS ingredients. FDA will review the 
information provided in response to this ANPRM before it proposes 
modifications to the current specifications for lead in these food and 
color additives and GRAS ingredients.

I. Background

A. Lead Toxicity

    Lead affects numerous essential body functions and has no known 
physiological value. The primary targets of lead are the central and 
peripheral nervous systems, the kidneys, and red blood cells. Recent 
scientific evidence indicates that lead has deleterious effects on 
human health at levels that were once thought to be innocuous. In fact, 
there is no known level of lead intake that does not produce adverse 
health effects.
    FDA discussed the well-documented adverse health effects of lead in 
an ANPRM on lead in food published in the Federal Register of August 
31, 1979 (44 FR 51233); in a proposed rule on the migration of lead 
from ceramic pitchers published in the Federal Register of June 1, 1989 
(54 FR 23485); in a proposed rule on tin-coated foil capsules for wine 
bottles published in the Federal Register of November 25, 1992 (57 FR 
55485); and in a proposed rule on lead-soldered food cans published in 
the Federal Register of June 21, 1993 (58 FR 33860). Also, the Centers 
for Disease Control and Prevention (CDCP) discuss lead's effects in 
their 1991 document entitled ``Preventing Lead Poisoning in Young 
Children'' (Ref. 1).
    In this ANPRM, FDA's primary concern is the effects of low levels 
of lead on fetuses, infants, and children from consumption of food and 
color additives and GRAS ingredients used in food. The adverse health 
effects of lead exposure in fetuses, infants, and children occur at 
lower blood lead levels than in adults. In particular, lead is harmful 
to the developing major organs, such as the brain and nervous system, 
of these sensitive population groups. Fetuses are sensitive to maternal 
dietary lead intake, especially during the development of their nervous 
systems. Further, infants and children ingest and absorb a larger 
amount of lead per unit of body weight than adults, and they also 
retain a larger fraction of absorbed lead.
    Blood lead levels of a large number of children in the United 
States remain above the toxicity standards recommended by the CDCP 
(Ref. 1). Additionally, recent studies show a correlation between 
impaired childhood development and lead exposure at levels as low as 10 
micrograms/deciliter (g/dL) of lead in blood and below. 
Decreased stature or growth, decreased hearing acuity, impaired 
neurobehavioral development, and decreased intelligence have all been 
linked to these low levels of lead exposure in children (Ref. 1). Lead 
also interferes with the synthesis of vitamin D and heme, the iron 
containing component of hemoglobin, at blood lead levels of 10 to 15 
g/dL.
    The symptoms of lead exposure at these low levels are not 
pronounced and are therefore difficult to assess. A technique of 
grouping data from different studies (meta-analysis), which enhances 
the ability to detect a true effect, has been used to retrospectively 
analyze 12 studies reported since 1981 on the relationship between 
childhood lead exposures and neurobehavioral development (Ref. 2). The 
results of this analysis strongly support the hypothesis that there is 
an inverse relationship between lead exposure and childhood 
intelligence quotient (IQ), even at very low doses. Similarly, a 
coordinated study by eight countries showed a significant relationship 
between increases in blood-lead concentration and decreases in 
behavioral test performance for blood-lead levels ranging from 5 to 60 
g/dL (Ref. 3).
    Long-lasting adverse effects from low level childhood lead 
exposures have also been observed. Early postnatal exposure results in 
decreased cognitive performance in the preschool and early school years 
(Refs. 4 and 5). Academic success and the fine motor skills of young 
adults were also shown to be inversely related to the amount of lead in 
the teeth shed by children in the first and second grades (Ref. 6).
    Fetuses are also at risk to low levels of lead. The available data 
show that the placenta is not a significant barrier to fetal lead 
uptake. Maternal and umbilical cord blood-lead levels of 10 to 15 
g/dL are associated with reduced gestational age and reduced 
weight at birth (Ref. 4). Additionally, there are several studies in 
which prenatal blood-lead levels were monitored, followed by monitoring 
of the blood-lead level and childhood development for several years 
after birth. In most of these studies, prenatal exposures were 
associated with slower sensory motor development and delayed early 
cognitive development (Ref. 1). Some of these associations may decrease 
as the child ages, if postnatal exposures are low, and subsequent 
socioeconomic conditions are favorable (Ref. 7).
    Adult exposure to lead has been associated with higher occurrences 
of cardiovascular disease when blood lead levels are as low as 25 to 30 
g/dL (Ref. 8). In particular, there is an increased incidence 
of high blood pressure, which may lead to an increase in hypertension-
related diseases. Red blood cell protoporphyrin elevation and 
peripheral nerve dysfunction have also been observed at these same 
blood lead levels (Ref. 8).
    As the amount and duration of lead exposure increases, lead's 
effects on the body become more severe. Blood-lead levels above 40 
g/dL in all population groups can result in permanent kidney 
damage, acute anemia, peripheral nerve dysfunction, and severe 
gastrointestinal symptoms. Higher levels of lead affect the central 
nervous system. Blood levels greater than 80 g/dL in children 
and greater than 100 g/dL in adults can lead to acute 
encephalopathy, characterized by massive accumulation of fluid in the 
brain, gross mental retardation in children, convulsions, coma, and 
even death (Ref. 8).

B. Sources of Lead

    Lead is ubiquitous in industrial societies. Known sources of lead 
include paint containing lead-based pigments, leaded gasoline, and lead 
solder. Lead exposure occurs through pathways such as food, air, dust, 
soil, and water. For children under 5 years of age, lead-based paint 
remains the primary source of high level lead poisoning, with ingestion 
of dust and soils contaminated with this paint being the primary 
exposure pathway. In contrast, low level lead exposure in all 
population groups is often caused by contributions through a variety of 
pathways, with no single source or pathway predominating. Because the 
effects of lead from all sources are additive, contributions from any 
single source should be well below the amount known to cause 
deleterious health effects.
    In 1990, FDA estimated that, on average, 16 percent of a 2-year-old 
child's lead intake was derived from food (Ref. 9). Most of the rest of 
the lead was ingested from dust (75 percent). FDA has also estimated 
that women of childbearing age ingest 43 percent of their lead from 
food and 53 percent from dust and water. Children, through play and 
normal hand-to-mouth activities, ingest larger amounts of lead from 
dust and soil than adults.
    Lead is introduced into food through a variety of pathways. It can 
enter the food chain through water, dust, soil, or air. Naturally 
occurring levels of lead in the environment are generally negligible 
compared to those caused by humans (Ref. 10). Lead in water comes 
primarily from the plumbing systems used for water distribution. 
Airborne lead, from the exhaust of cars and machinery that use leaded 
gasoline and from industrial activities that emit lead, can be 
deposited directly on plants. Lead is also deposited on soil from these 
sources. In addition, lead in soils is in part the result of the 
historical use of lead-based pesticides. Lead deposited on soil remains 
a long-term source of lead exposure because it does not biodegrade or 
decay, and it is immobilized by the organic component of soil (Ref. 
10).
    Food processing also contributes lead to food. Lead can be 
introduced through the machinery and water used in food processing, 
from food and color additives and GRAS ingredients used in food, and 
from food packaging. Cans with lead-soldered seams have been a 
predominant source of lead contamination in food in the recent past. If 
lead-based paint is present in a food manufacturing or processing 
facility, paint dust containing significant quantities of lead may also 
contaminate the food.

II. Previous Regulatory Action on Lead

A. FDA Actions

    FDA has been involved in reducing the amount of lead in the diet 
since the 1930's. Initial efforts were aimed at controlling the use of 
lead-containing pesticides on fruits and vegetables. Subsequent 
attention has been directed at lead contributions from a variety of 
sources including ceramicware, lead-soldered food cans, and tin-lead 
capsules for wine bottles.
    In the Federal Register of August 31, 1979 (44 FR 51233), the FDA 
published an ANPRM (the 1979 ANPRM) that described the sources of lead 
in foods, the health concerns arising from the presence of lead in 
foods, and the agency's plan to reduce the level of dietary lead intake 
derived from the use of lead solder in food cans. The 1979 ANPRM 
identified the maximum tolerable level of total lead intake from all 
sources. The notice also announced the agency's tentative plan to 
reduce contributions of lead from other sources in foods and requested 
information on existing lead levels in foods.
    The agency also published a proposed rule in the Federal Register 
of June 1, 1989 (54 FR 23485) that proposed limitations on the amount 
of lead that could leach from ceramic pitchers (excluding creamers) 
that are intended for food contact. This document also proposed that 
decorative ceramicware that leaches high lead levels must be 
permanently labeled or modified in such a way as to preclude its use 
for holding foods. The agency recently revised its Compliance Policy 
Guide to include lower enforcement level guidelines for ceramic 
foodware (July 6, 1992, 57 FR 29734).
    Beginning in 1992, FDA has accelerated its actions to reduce the 
level of lead in food. In the Federal Register of November 25, 1992 (57 
FR 55485), the agency published a proposed rule to prohibit the use of 
tin-coated lead foil capsules as coverings on wine bottles. This action 
was based on evidence that under ordinary conditions of use, lead in 
these capsules can become a component of wine. In that document, the 
agency discussed the relationship between lead exposure and lead in 
blood and tentatively defined a provisional tolerable total intake 
level (PTTIL) for lead from all food and non-food sources. The agency 
calculated the PTTIL based on the most up-to-date knowledge of lead's 
lowest toxic effect levels. The agency tentatively set the PTTIL at 25 
micrograms per day (g/day) for pregnant women, who are 
surrogates for fetal exposure, and 75 g/day for other adults. 
These values are provisional because they are based on the current 
lowest observed effect level (LOEL) of lead in the blood (30 
g/dL for adults and 10 g/dL for infants, children, 
and pregnant women), which may need to be reduced further if additional 
research shows that even lower blood-lead levels cause adverse health 
effects.
    In a proposed rule published in the Federal Register of January 5, 
1993 (58 FR 389), the agency proposed to establish a maximum level of 
0.005 milligram per liter (mg/L) as the quality standard for lead in 
bottled water.
    In a proposed rule published in the Federal Register of June 21, 
1993 (58 FR 33860), the agency proposed to ban the use of lead solder 
for domestic and imported food cans. In that document, the agency 
tentatively defined the PTTIL for infants and children. The agency used 
the LOEL of 10 g/dL to arrive at a PTTIL of 6 g/day 
for infants and children (Ref. 8). This lower PTTIL is based on the 
fact that children absorb lead more efficiently than do adults. In a 
notice published in the Federal Register of April 1, 1993 (58 FR 
17233), the agency also announced emergency action levels for lead in 
foods packed in lead-soldered cans. These action levels are an interim 
measure to protect infants and young children from adverse effects that 
could result from daily consumption of foods packaged in lead-soldered 
cans, pending completion of the rulemaking to prohibit the use of lead 
solder in food cans.
    In a final rule published in the Federal Register of January 12, 
1994 (59 FR 1638), the agency amended its regulations to require that 
decorative ceramicware, which may leach hazardous amounts of lead into 
food, bear adequate indications to distinguish it from ceramic foodware 
(i.e., ceramicware intended for holding, storing, or serving food). 
This rule requires a statement and a stick-on label on the exterior 
surface of the decorative ceramicware that the piece is not for food 
use, and that it may poison food. Alternatively, the rule provides that 
a hole may be bored through the possible food-contact surface of the 
piece.

B. Other Federal Agency Actions

    The elimination of lead poisoning is a coordinated effort by 
several Federal agencies. In 1988, the Agency for Toxic Substances and 
Disease Registry (ATSDR) published a report to Congress summarizing the 
nature and extent of lead poisoning in children. The report found that 
in 1984, 17 percent of metropolitan preschool children had blood lead 
levels that exceeded 15 g/dL (Ref. 11). In February 1991, the 
Department of Health and Human Services announced a ``Strategic Plan 
for the Elimination of Childhood Lead Poisoning.'' This document called 
for a concerted, society-wide elimination effort and described the need 
for a more comprehensive evaluation of blood lead levels and 
environmental lead contamination (Ref. 1).
    CDCP also addressed the issues of lead toxicity and poison 
prevention in children in their October 1991 document entitled 
``Preventing Lead Poisoning in Young Children'' (Ref. 1). This document 
included multitiered program, based on blood lead levels, that CDCP 
devised to replace the previous single definition of lead poisoning. 
The CDCP threshold for initiating action to reduce lead exposure was 
lowered from 25 g/dL to 10 g/dL in children because 
of the large amount of data showing lead's deleterious effects on 
development at blood lead levels of 10 g/dL and above. The 
CDCP are also helping laboratories to improve the reliability of blood 
lead measurements and are developing improved instrumentation for 
analysis of blood lead levels.
    In 1978, the Consumer Product Safety Commission (CPSC) banned both 
paint containing more than 0.06 percent lead by weight and the 
deliberate addition of lead to paint for use on residential surfaces, 
toys, and furniture. In addition, in the Federal Register of April 30, 
1992 (57 FR 18418), the CPSC announced that it was investigating the 
further reduction of this maximum allowable limit to 0.01 percent. 
Lead-based paint is still available for industrial, marine, and 
military use.
    In a plan for the abatement of lead-based paint published in 1990, 
the U.S. Department of Housing and Urban Development (HUD) found that 
approximately 74 percent of occupied, privately-owned houses built 
before 1980 still contained lead-based paint. The CDCP report (Ref. 1) 
summarizes the results of this report and discusses methods for 
decreasing lead exposure in houses painted with lead-based paint.
    The Environmental Protection Agency (EPA) has been working for many 
years on the removal of lead in gasoline, pesticides, and, more 
recently, drinking water (June 7, 1991, 56 FR 26460). EPA has also 
recently released a report to Congress outlining a strategy to reduce 
human lead exposures from the environment, as summarized in the CDCP 
report (Ref. 1). As part of this strategy, EPA published a final rule 
on June 30, 1993 (58 FR 35314), that decreased the minimum quantity of 
several lead compounds, as emissions from manufacturing facilities, 
that must be reported to the agency.

III. Lead in Food and Color Additives and Gras Ingredients

A. Exposure to Lead from Food and Food Ingredients

    Based upon the results of FDA's Total Diet Study (the agency's 
annual market-basket survey of foods (Ref. 12)), from 1988 through 
1990, FDA estimates that 2-year-old children consume about 4.5 
g of lead each day from food alone, while women of 
childbearing age consume about 9 g/day (Ref. 9). For a 2-year-
old child, lead intake from food is nearly equal to the PTTIL of 6 
g/day for lead from all sources, even though food is estimated 
to account for only 16 percent of the child's total daily intake of 
lead (Ref. 9).
    In its 1988 report to Congress, ATSDR estimated that, in 1987, 
approximately 1 million young children in this country consumed 
sufficient lead in food to cause blood lead levels of 10 g/dL 
and greater (Ref. 11).
    The relation between dietary lead and lead uptake in the body is 
complex. Absorption of lead from the gastrointestinal (GI) tract in 
adults is normally about 10 to 15 percent, but it can be as high as 45 
percent under fasting conditions (Ref. 8). This difference may be 
important, for example, when foods containing lead are consumed between 
meals. It has been empirically estimated that for low exposures, 
resulting in blood lead levels of up to 30 g/dL, the ingestion 
of 1 g of lead per day in the diet results in an increase of 
0.04 g/dL of lead in the blood of adults (Ref. 13).
    Children are even more efficient at absorbing lead through the GI 
tract than are adults, with a rate of absorption of approximately 50 
percent (Ref. 8). In children, for exposures resulting in blood lead 
levels up to 10 g/dL, every microgram of lead ingested per day 
from the diet increases the blood lead level by 0.16 g/dL. 
This level is approximately four times as much lead in the blood per 
equivalent dose as in adults.

B. Need for Action to Lower Lead Specifications

    Since FDA began to regulate food additives in 1958, the agency has 
generally considered that the public health was adequately protected by 
specifications of 3 ppm for arsenic, 10 ppm for lead, and 40 ppm for 
total heavy metals (as lead) (Ref. 14). The agency believed that these 
specifications could readily be met in food additives produced under 
current good manufacturing practice (CGMP) conditions, and that these 
specifications would ensure that food additives would not contribute 
significant amounts of heavy metals to the diet. The agency also 
believed that the actual heavy-metal levels achieved through adherence 
to CGMP's would be significantly lower than these limits (Ref. 15).
    When the Food Chemicals Codex was established by the National 
Academy of Sciences (NAS) in 1961, the Food Chemicals Codex committee 
adopted these specifications for nearly all food additives. These 
levels have remained until recently as the levels used as guidance in 
establishing specifications in Food Chemicals Codex monographs for food 
ingredients.
    However, with today's increased knowledge of lead's deleterious 
effects at low ingestion levels, it is necessary to decrease lead 
specifications for food and color additives and GRAS ingredients to 
protect the public health. Specifications must be set at the lowest 
lead levels attainable through the diligent application of CGMP's to 
ensure that lead is reduced to its lowest possible levels in food.
    The potential exists, with the high current levels of lead 
specifications, that food and color additives and GRAS ingredients will 
contribute significant amounts of lead to the diet. Even if most food 
ingredients do not contain the maximum amount of lead permitted by the 
specifications, lead ingested from the use of food and color additives 
and GRAS ingredients will comprise a small, although not readily 
quantifiable, percentage of a person's total dietary lead intake. 
Because low level lead exposure is often the result of contributions 
from multiple small sources, significant reductions in a person's 
overall lead exposure can result from reductions in the levels of lead 
in many of those sources. Although some sources may be difficult to 
control, the agency believes that industry has the ability to reduce 
lead levels in food and color additives and GRAS ingredients, either 
through tighter control of starting material purities or improvements 
in manufacturing processes.
    To illustrate the potential lead exposure from food and color 
additives and GRAS ingredients, FDA has calculated the possible per 
capita lead intake from the use of those additives and GRAS ingredients 
that are added to the U.S. food supply in amounts greater than 25 
million pounds per year\1\. These high consumption substances 
(currently 38) constitute over 80 percent by weight of all substances 
in the 1987 NAS survey. The agency recognizes that the absolute 
poundages of these substances may not be accurately portrayed in the 
survey because the information is voluntarily reported. However, the 
agency believes that the data accurately reflect the relative ranking 
of the substances. Therefore, the data are useful for illustrative 
purposes and can serve as a means of prioritizing actions on food 
ingredients based on relative usage levels.
    The 38 substances are listed in Table 1 in decreasing order of 
reported use, along with their maximum lead specifications. When 
possible, the lead specifications that are either listed or referenced 
in FDA regulations for lead or heavy metals (as lead) are shown. If no 
lead specification is referenced in FDA regulations, the most recent 
specification in the Food Chemicals Codex (Refs. 16 through 18) is 
listed. For the few food substances that have no lead specification, 
FDA used a lead level of 1 ppm to calculate the potential lead 
exposure. 

               Table 1--Most Widely Used Food Substances and Their Current Lead Specifications\1\               
----------------------------------------------------------------------------------------------------------------
           Substance\2\               Lead Limit\3\ ppm             Substance\2\             Lead Limit\3\ ppm  
----------------------------------------------------------------------------------------------------------------
High fructose corn syrup                     0.5           d-Sorbitol                              10.0         
Sucrose                                      0.5           Lactose                                  -           
Corn syrup                                   0.5           Calcium oxide                           10.0         
Corn gluten                                  -             Sodium bicarbonate                       5.0         
Soybean oil                                  0.1           Mono-diglycerides                       10.0         
Sodium chloride                              4.0           Palm kernel oil                          0.1         
Sucrose liquid                               -             Phosphoric acid                         10.0         
Corn oil                                     0.1           Maltodextrin                             0.5         
Dextrose                                     0.1           Iron, reduced                           25.0         
Whey                                        10.0           Niacin                                  20.0         
Calcium carbonate                           10.0           Sodium phosphate, di-                   10.0         
Coconut oil                                  0.1           Monosodium glutamate                    10.0         
Caramel                                     10.0           Peanut oil                               0.1         
Diatomaceous earth                          10.0           Casein                                   5.0         
Starch, food, modified                       5.0           Azodicarbonamide                        10.0         
Cottonseed oil                               0.1           Calcium sulfate                         10.0         
Cocoa butter substitute                     10.0           Sulfuric acid                            5.0         
Sodium hydroxide                            10.0           Glycerin                                 5.0         
Citric acid                                 10.0           Sodium citrate                          10.0         
----------------------------------------------------------------------------------------------------------------
\1\Substances are listed in decreasing order of poundage. High volume substances (poundages greater than 100    
  million pounds per year) are listed on the left, while moderate volume substances (25 million to 100 million  
  pounds per year) are on the right.                                                                            
\2\Boldface substances have specifications in the Code of Federal Regulations.                                  
\3\The type of lead specification is indicated by the font type: Boldface type means that the level is an actual
  lead specification, italics mean that the lead level is from a specification denoted ``heavy metals as lead,''
  and a dash indicates that there is no available lead specification.                                           

    Based upon the lead levels listed and the per capita intake of 
these substances, FDA calculates that the theoretical maximum per 
capita intake of lead from the food use of these 38 widely used 
substances could reach 164 g/day if all lead levels were at 
their maximum specification limits. Although it is clear from FDA's 
total diet study (Ref. 9) that the amount of lead consumed (4.5 
g/day for a 2-year-old child and 9 g/day for women of 
childbearing age) is not nearly as high as the sum of these 
specifications would permit, the calculation illustrates the potential 
lead exposure if food and color additives and GRAS ingredients were 
consistently produced with lead levels near the specification limits. 
It also demonstrates that these specification levels are collectively 
well in excess of the levels of lead in the ingredients actually being 
added to food.
---------------------------------------------------------------------------

    \1\This calculation is based upon disappearance data from a 1987 
survey by the NAS on the quantities of food substances added by the 
U.S. industry to food (Ref. 19). FDA recognizes that disappearance 
data identify the amounts of substances available for use in food 
and food processing, but do not necessarily mean that all of these 
amounts are consumed in food.
---------------------------------------------------------------------------

    The agency has also calculated the potential effect on the 
ingestion of lead if all of the lead specifications for these 38 
substances were reduced. If the agency were to replace the current lead 
specifications with lower lead levels of 0.1 ppm for high volume 
substances (those with disappearance poundages greater than 100 million 
pounds/year) and 0.5 ppm for those of moderate volume (between 25 
million and 100 million pounds per year), FDA has estimated that the 
theoretical per capita intake of lead from these 38 most widely used 
food ingredients could be reduced from 164 g/day to 13 
g/day (Refs. 19 and 20). Although lead levels are generally 
not as high as current lead specifications allow, lowering these 
specifications is likely to have the effect of lowering lead exposure. 
Manufacturers will be more concerned about monitoring and controlling 
the lead content of their products to ensure that the lead levels are 
substantially below the new specification levels, and that the normal 
variations in lead content that occur from batch to batch do not 
produce a violative product. Also, lower lead specifications will 
protect subsets of the population that might eat food that has been 
produced with food ingredients containing unusually high lead levels, 
if, for example, a particular manufacturer uses a process that results 
in the food ingredient having a higher level of lead than average.
    As a further illustration, the agency has calculated the potential 
decrease in lead intake from reduction of lead specifications in a 
specific color additive, caramel. Caramel currently has a 10 ppm lead 
limit specification in FDA regulations (21 CFR 73.85). However, the 
food industry usually controls for contaminants at levels that are 
significantly lower than the established specification levels to ensure 
that all production batches will be in compliance. From informal 
conversations with industry, the agency believes that a reasonable 
control level might be one-fifth the specification level. Using the 
data from the 1987 NAS poundage survey (Ref. 19), and assuming that all 
caramel is produced with lead levels at one-fifth the specification, or 
2 ppm, the agency calculates that the potential per capita lead 
exposure from caramel could still be as high as 1.6 g/day. 
Reducing the specification to 0.1 ppm could result in a potential 100-
fold reduction in lead levels in caramel.
    High fructose corn syrup (HFCS), one of the most heavily used food 
ingredients in the United States according to the NAS poundage survey, 
illustrates the efforts industry has made to aid FDA and a Food 
Chemicals Codex committee in setting lower lead specifications that 
more accurately reflect actual lead levels. HFCS has been commercially 
produced since 1967, and FDA listed HFCS containing 43 percent fructose 
as GRAS in 1983 (21 CFR 182.1866). The listing, however, does not 
include any specifications for impurities such as lead. In the absence 
of lead specifications, industry was guided by the Food Chemicals Codex 
committee's general impurities policy that included a 10 ppm lead 
specification (Ref. 16). It was not until 1986 that a Food Chemicals 
Codex monograph was developed for HFCS, which set a lead specification 
of 1 ppm (Food Chemicals Codex, 3d ed., 2d supp. (Ref. 17)). The Food 
Chemicals Codex lead specification was further reduced in 1992 to 0.5 
ppm as a result of cooperative interactions between FDA, the Food 
Chemicals Codex, and industry. In response to a request by the agency 
in 1990, industry provided preliminary data on lead levels in a small 
sampling of HFCS measured by methods that are more sensitive than 
routine quality control methods. Actual lead levels ranged between 
0.002 and 0.073 ppm in the samples analyzed (Refs. 21 and 22). Although 
measurements with this level of sensitivity are not yet done on a 
routine basis, these results suggest the actual amounts of lead in 
HFCS. Using these measurements, a 12-ounce (oz) can of soda that 
contains 10 percent HFCS probably contains lead in the range of 0.07 to 
2.6 g, whereas existing lead specifications would allow 18 
g of lead. Lowering the specification for lead in HFCS to 0.1 
ppm would reduce the maximum allowable lead from HFCS in a 12 oz can of 
soda to 3.6 g.

C. Changes in Food Chemicals Codex Lead Specifications

    As part of FDA's initiative to reduce lead in food, the agency has 
been working with the Food Chemicals Codex committee of the NAS to 
review lead specifications for selected food ingredients. The 3d 
edition of the Food Chemicals Codex and its four supplements contain 
specifications and analytical methodologies for over 900 food 
ingredients. The specifications are used by food processors and 
manufacturers of food ingredients in the United States and in other 
countries as guidelines for their products' purity. The specifications 
are also often incorporated by reference into FDA's regulations for 
food and color additives and GRAS ingredients.
    The agency's concerns regarding lead levels in food ingredients 
were presented to the Food Chemicals Codex committee during a workshop 
on May 2, 1991. For many substances, the Food Chemicals Codex currently 
specifies a 10-ppm lead limitation (see section III.B. of this 
document). Following the workshop, the Food Chemicals Codex committee 
updated its policy for establishing lead specifications for food 
ingredients. Previously, lead specifications were set at the lowest 
practicable levels based on CGMP and the capability of analytical 
methodology to determine the lead level in individual food ingredients. 
The Food Chemicals Codex committee's policy, announced in the Federal 
Register of July 15, 1993 (58 FR 38129), now provides that the Food 
Chemicals Codex will set lead specifications by also considering the 
estimated lead intake from use of the food ingredient and the potential 
health hazard of these intake levels, in a fashion similar to that 
which the agency is considering.
    As an outgrowth of the Food Chemicals Codex committee workshop, new 
and revised lower lead specifications have been published for several 
food ingredients in the Food Chemicals Codex (3d ed., 3d supp. (Ref. 
18)). For example, included are lead specifications of 0.1 ppm for 
dextrose and fructose and 0.5 ppm for less refined products, such as 
glucose syrups, maltodextrin, and polydextrose. The Food Chemicals 
Codex committee has been reviewing and revising the lead specifications 
for other food and color additives and GRAS ingredients as well (Ref. 
23). The Food Chemicals Codex committee is expected to continue 
reducing lead specifications in future monograph revisions for 
inclusion in the fourth edition of the Food Chemicals Codex.

IV. Changes in FDA Lead Specifications

    Because of the possibility that significant amounts of lead might 
be introduced into food from regulated food and color additives and 
GRAS ingredients, and because of the increased knowledge of the 
deleterious health effects of low level lead exposure, FDA has started 
to take action to limit the potential dietary intake of lead from these 
sources. Based on the considerations discussed in section III. of this 
document, the agency is focusing on high and moderate consumption 
substances, such as those listed in Table 1 of this document.
    The agency has begun requesting that information on lead levels be 
included in certain food and color additive and GRAS affirmation 
petitions. FDA is asking that petitions for either new uses of 
regulated high and moderate consumption substances, or new substances 
that are expected to be consumed in significant quantities, show that 
lead levels in the petitioned products are as low as CGMP's allow. 
Given the toxicity of lead, such evidence is necessary if the agency is 
to make a determination on the safety of the additive for its proposed 
use. The agency will evaluate the data that it receives on lead levels 
during the petition review process and set lead specifications at 
levels that are necessary to ensure that there is a reasonable 
certainty of no harm from use of the additive.
    Lower specifications, to be meaningful, will need to be supported 
by analytical methods that allow quantification of lead at the reduced 
levels. Recent advances in instrumentation should allow for reliable, 
quantitative detection of lead in food ingredients at much lower levels 
than possible with previous analytical methods. For example, in the 
Food Chemicals Codex (3d ed., 3d supp. (Ref. 18)), a graphite furnace 
atomic absorption spectrophotometric method is described that detects 
lead in substances such as edible oils at levels less than 1 
g/g (1 ppm) of lead. A similar method has been developed for 
nutritive sweeteners (Ref. 24). Development of more sensitive routine 
analytical procedures or expertise in more sophisticated methods will 
facilitate routine testing for lead below 0.1 ppm and will enable 
industry to further control and eliminate lead from food ingredients. 
Thus, the agency is asking petitioners to provide analytical 
methodologies that are capable of detecting lead at sub-ppm levels and 
to show that these methodologies have been validated.
    FDA recognizes the need to lower its lead specifications for high 
and moderately high consumption food and color additives and GRAS 
ingredients to ensure that their use is safe. Thus, in the absence of 
persuasive comments to the contrary, the agency intends to propose 
setting specifications at 0.1 ppm lead for high-poundage ingredients 
(greater than 100 million pounds per year, such as substances in the 
left column of Table 1) and 0.5 ppm lead for moderately high-poundage 
ingredients (between 25 and 100 million pounds per year, such as 
substances in the right column of Table 1). FDA plans to propose 
establishing these specifications for new ingredients, new uses of 
previously regulated ingredients, and currently regulated ingredients. 
Also, FDA is considering only adopting Food Chemicals Codex lead 
specifications for individual ingredients when it finds that the levels 
are low enough to protect the public health.
    Comments on these approaches to setting specifications for lead, 
and suggestions for alternative approaches for developing consistent 
lead specifications for all current and future uses of food and color 
additives and GRAS ingredients that still protect the public health, 
are requested.

V. Request for Information

    Although FDA has extensive information concerning lead in its 
files, additional information on the following topics will greatly 
assist the agency both in setting specifications for lead in food and 
color additives and GRAS ingredients and in minimizing the exposure to 
lead in a consistent manner:
    1. Current data on actual lead levels in: (a) Food and color 
additives and GRAS ingredients, the variation in these levels, and 
suggested lead specifications for each substance. Of particular 
interest are the high consumption substances in the left column of 
Table 1 of this document and the moderate consumption substances in the 
right column of Table 1. Also of interest are other substances that, 
although consumed at a lower rate, contain sufficiently high levels of 
lead to be of concern; (b) agricultural commodities that are raw 
materials for many food ingredients; and (c) nutrient supplements 
(e.g., calcium, iron).
    2. Analytical methods for detecting sub-ppm levels of lead in food 
components, including detection limits, reliability of the methods for 
different food and color additives and GRAS ingredients, and validation 
data. Of particular interest are improvements in graphite furnace 
atomic absorption spectrophotometry and studies of its applicability to 
the 38 substances listed in Table 1.
    3. Information on the potential economic impact, if any, associated 
with the manufacture of the 38 food and color additives and GRAS 
ingredients listed in Table 1 if the lower lead levels are adopted. FDA 
is required to assess the economic consequences of any regulation it 
proposes, but it does not possess data that would permit detailed 
assessment of the economic impact of adopting lower lead 
specifications.
    4. Information on the potential environmental impact that may be 
associated with the manufacture of the 38 food and color additives and 
GRAS ingredients if lower lead specifications are adopted. Under the 
National Environmental Policy Act, FDA must consider the environmental 
impact of its actions. However, the agency does not now possess the 
data that would permit detailed analysis of the environmental impact of 
adopting lower lead levels. Therefore, the agency is requesting 
environmental information that includes, but is not limited to, the 
following: (a) A description of the additional steps, if any, required 
to produce these food and color additives and GRAS ingredients with the 
reduced lead specifications and of the environmental impact of these 
steps; (b) the environmental impact of additional testing, if any, 
performed to ensure compliance with the lower lead specifications; and 
(c) a description of measures that could be taken to avoid or mitigate 
adverse environmental impacts, if such impacts are predicted to result 
from this action.

VI. Conclusion

    FDA has had a longstanding goal of reducing lead exposure from all 
dietary sources. Because lead is ubiquitous, and exposure to lead is 
from a multitude of different sources, lead levels from each source 
must be sufficiently low to ensure that a person's total lead exposure 
is not harmful. The agency believes that lead specifications in food 
and color additives and GRAS ingredients can be lowered to help achieve 
this goal and protect the public health. Therefore, the agency intends 
to lower lead specifications in food and color additives and GRAS 
ingredients that are consumed in large amounts by the general 
population to levels that will offer adequate protection.
    FDA plans to propose lead specifications of 0.5 ppm for moderate 
consumption food ingredients and 0.1 ppm for high consumption food 
ingredients. The agency is requesting information on current lead 
levels in food ingredients and analytical methods for determining these 
lead levels, and on the economic and environmental effects of complying 
with these specifications. The information received in response to this 
ANPRM will be used to determine the feasibility of adopting these 
target specifications. The agency intends to propose these 
specifications unless information is submitted to show that such levels 
are not feasible and higher specifications will not endanger the public 
health.

VII. 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. CDCP, Department of Health and Human Service, Public Health 
Service, ``Preventing Lead Poisoning in Young Children,'' October 
1991.
    2. Needleman, H. L., and C. A. Gatsonis, ``Low-Level Lead 
Exposure and the IQ of Children,'' Journal of the American Medical 
Association, 263:673-678, 1990.
    3. Winneke, G., A. Brockhaus, U. Ewers, U. Kramer, and M. Neuf, 
``Results from the European Multicenter Study on Lead Neurotoxicity 
in Children: Implications for Risk Assessment,'' Neurotoxicity and 
Teratology, 12:553-559, 1990.
    4. Bellinger, D., A. Leviton, C. Waternaux, H. Needleman, and M. 
Rabinowitz, ``Longitudinal Analyses of Prenatal and Postnatal Lead 
Exposure and Early Cognitive Development,'' New England Journal of 
Medicine, 316:1037-1043, 1987.
    5. Baghurst, P. A., A. J. McMichael, N. R. Wigg, G. V. Vimpani, 
E. F. Robertson, R. J. Roberts, and S. L. Tong, ``Environmental 
Exposure to Lead and Children's Intelligence at the Age of Seven 
Years: The Port Pirie Cohort Study,'' New England Journal of 
Medicine, 327:1279-1284, 1992.
    6. Needleman, H. L., A. Schell, D. Bellinger, A. Leviton, and E. 
N. Allred, ``The Long-Term Effects of Exposure to Low Doses of Lead 
in Childhood: an 11-year Follow-up Report,'' New England Journal of 
Medicine, 322:83-88, 1990.
    7. Bellinger, D., J. Sloman, A. Leviton, M. Rabinowitz, H. L. 
Needleman, and C. Waternaux, ``Low-Level Lead Exposure and 
Children's Cognitive Function in the Preschool Years,'' Pediatrics, 
87:219-227, 1991.
    8. Memorandum, dated November 18, 1991, from Contaminants Team, 
Standards and Monitoring Branch, to Additives Evaluation Branch, 
``Clarification of Terminology Used in the Development of the 
Provisional Total Tolerable Intake Levels for Lead.''
    9. Bolger, P. M., C. D. Carrington, S. G. Capar, and M. A. 
Adams, ``Reductions in Dietary Lead Exposure in the United States,'' 
Chemical Speciation and Bioavailability, 3:31-36, 1991.
    10. Elias, R. W., ``Lead Exposures in the Human Environment,'' 
in Dietary and Environmental Lead: Human Health Effects, edited by 
K. R. Mahaffey, Elsevier Science Publishers, B. V., Amsterdam, pp. 
79-107, 1985.
    11. Agency for Toxic Substances and Disease Registry, Public 
Health Service, ``The Nature and Extent of Lead Poisoning in 
Children in the United States: A Report to Congress,'' pp. (VI-44)-
(VI-49), July 1988.
    12. Pennington, J. A. T. and E. L. Gunderson, ``History of the 
Food and Drug Administration's Total Diet Study--1961 to 1987,'' 
Journal of the Association of Official Analytical Chemists, 70:772-
782, 1987.
    13. Carrington, C. D. and P. M. Bolger, ``An Assessment of the 
Hazards of Lead in Food,'' Regulatory Toxicology and Pharmacology, 
16:265-272, 1992.
    14. Excerpts from ``Chemical Problems Encountered in the 
Administration of the Food Additives Amendment,'' a speech given by 
L. L. Ramsey at ``Symposium on Analytical Methods for Food Additive 
and Pesticide Chemicals,'' American Chemical Society, New York, NY, 
September, 1960.
    15. Excerpt from Food Chemicals Codex Advisory Panel Bulletins, 
December 1962, letter from Dr. Henry Fischbach, FDA, to Dr. Justin 
L. Powers, Food Chemicals Codex Director, NAS.
    16. Food Chemicals Codex, 3d ed., National Academy Press, 
Washington, DC, 1981.
    17. Food Chemicals Codex, 3d ed., 2d supp., National Academy 
Press, Washington, DC, 1986.
    18. Food Chemicals Codex, 3d ed., 3d supp., National Academy 
Press, Washington, DC, 1992.
    19. Memorandum, dated July 17, 1992, from Food and Color 
Additives Review Section, to Indirect Additives Branch, ``Lead in 
Food Additives--Hypothetical Effects on Dietary Lead Intake of 
Lowering Lead Specifications.''
    20. Memorandum, dated December 16, 1993, from Chemistry Review 
Branch, to Indirect Additives Branch, ``Lead in Food Additives. 
Fructose Disappearance Data and Predicted Lead Intake. Request for 
Additional Information dated 12-14-93.''
    21. Letter, dated February 5, 1990, from Kyd D. Brenner, Corn 
Refiners Association, Inc., to John W. Gordon, FDA.
    22. Letter, dated March 22, 1990, from Kyd D. Brenner, Corn 
Refiners Association, Inc., to John W. Gordon, FDA.
    23. Bigelow, S. W., ``Role of the Food Chemicals Codex in 
Lowering Dietary Lead Consumption: A Review'' Journal of Food 
Protection, 55:455-458, 1992.
    24. ILSI North America, Subcommittee on Trace Minerals in Foods, 
``Report to the FCC Committee on Methodology for Lead in 
Sweeteners,'' June 28, 1993.

VIII. Comments

    Interested persons may, on or before May 5, 1994, submit to the 
Dockets Management Branch (address above) written comments regarding 
this advance notice of proposed rulemaking. 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.
    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.

    Dated: January 12, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-2472 Filed 2-3-94; 8:45 am]
BILLING CODE 4160-01-F