Protection of Stratospheric Ozone; Methyl Bromide

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[FRL-6013-9]

Protection of Stratospheric Ozone; Methyl Bromide

AGENCY: Environmental Protection Agency.

ACTION: Notice of clarification.

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SUMMARY: This document clarifies a previous statement by EPA about the

applicability of a Clean Air Act labeling rule to methyl bromide as a

``class I ozone-depleting substance.'' The labeling rule requires

products ``containing'' or ``manufactured with'' a class I ozone-

depleting substance to be labeled as such. This document makes clear

that any product, including any agricultural product, that ``contains''

or is ``manufactured with'' methyl bromide is subject to the labeling

rule's requirements. At the same time, EPA is not aware of any

agricultural product that ``contains'' or is ``manufactured with''

methyl bromide, as those terms are defined by the labeling rule. In

particular, raw food commodities grown for the fresh food market and

produced with the use of methyl bromide do not meet the definitions of

products ``containing'' or ``manufactured with'' methyl bromide and are

thus not subject to the labeling rule's requirements.

DATES: The effective date of this Notice of Clarification is May 15,

1998.

ADDRESSES: Comments and data relating to the methyl bromide rule are

contained in Air Docket A-92-13, U.S. Environmental Protection Agency,

OAR Docket and Information Center, Room M-1500, 401 M Street, S.W.,

Washington, D.C. 20460. Comments and data relating to the labeling rule

are contained in Air Docket A-91-60, at the same location. Each of the

dockets may be inspected between 8 a.m. and 5:30 p.m. on weekdays. The

telephone number for the dockets is (202) 260-7548; the fax number is

(202) 260-4400. As provided in 40 CFR, Part 2, a reasonable fee may be

charged for photocopying.

FOR FURTHER INFORMATION CONTACT: Carol Weisner at (202) 564-9193 or fax

(202) 565-2096, Stratospheric Protection Division, USEPA, Mail Code

6205J, 401 M Street, SW., Washington, DC 20460. Overnight mail (Fed-Ex,

Express Mail, etc.) should be sent to our 501 3rd Street, NW.,

Washington, DC 20001 street address.

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SUPPLEMENTARY INFORMATION:

I. Background Information

A. Stratospheric Ozone Protection

Added in 1990, Title VI of the Clean Air Act (``CAA'' or ``Act'')

establishes a comprehensive program to protect stratospheric ozone,

which helps shield the earth from harmful ultraviolet radiation. In

particular, it requires EPA to list substances that have a significant

potential to deplete stratospheric ozone as class I ozone-depleting

substances, and to require their phaseout by a specified date. It also

provides for a multi-faceted regulatory program to minimize the use and

release of ozone-depleting substances prior to their phaseout.

B. Labeling Rule

Section 611 of the Act prohibits the introduction into interstate

commerce of any product containing a class I substance or manufactured

with a process using a class I substance, unless it bears a warning

statement indicating that the product contains or is manufactured with

ozone-depleting substances. To implement this and other provisions of

section 611, EPA issued a final rule on February 11, 1993, at 58 FR

8136, which established labeling requirements for, among other things,

products containing, or manufactured with a process that uses, a class

I ozone-depleting substance (the ``labeling rule.'')

The labeling rule defines a ``product containing'' a class I

substance as a ``product including, but not limited to, containers,

vessels, or pieces of equipment, that physically holds a controlled

substance [i.e., a class I or II ozone-depleting substance] at the

point of sale to the ultimate consumer which remains within the

product.'' The rule also defines ``manufactured with a controlled

substance'' as follows:

[T]he manufacturer of the product itself used a controlled

substance directly in the product's manufacturing, but the product

itself does not contain more than trace quantities of the controlled

substance at the point of introduction into interstate commerce. The

following situations are excluded from the meaning of the phrase

``manufactured with'' a controlled substance:

(1) Where a product has not had physical contact with the

controlled substance;

(2) Where the manufacturing equipment or the product has had

physical contact with a controlled substance in an intermittent

manner, not as a routine part of the direct manufacturing process;

(3) Where the controlled substance has been transformed, except

for trace quantities; or

(4) Where the controlled substance has been completely

destroyed.

The current labeling requirements are codified at 40 CFR Part

82, Subpart E (including sections 82.100-82.124).1

\1\ In a January 19, 1995, rulemaking (60 FR 4010), the labeling

rule was revised. Among other revisions, the definition of

``manufactured with'' was amended to indicate that a product

``manufactured with'' a controlled substance does not contain more

than trace quantities of the controlled substance. The definition

was also amended to expand the situations that are excluded from the

phrase ``manufactured with'' to include where a product has physical

contact with a controlled substance only in an intermittent manner

and not as a routine part of the direct manufacturing process and

where the controlled substance has been completely destroyed.

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Section 82.102(a) of the labeling rule specifically provides that,

in the case of any substance designated as a class I substance after

February 11, 1993, the labeling requirements are applicable beginning

one year after the designation of such substance, unless the rulemaking

designating such substance provides otherwise.

C. Methyl Bromide Rule

EPA issued a final rule on December 10, 1993, at 58 FR 65018,

pursuant to sections 602 and 604 of the CAA, listing methyl bromide as

a class I ozone-depleting substance and establishing a phaseout date

for its production and importation (the ``methyl bromide rule.'')

Methyl bromide is used as a pesticide and fumigant.

The labeling rule became applicable to methyl bromide on January 1,

1995, one year following the effective date of its designation as a

class I substance. In the preamble to the methyl bromide rule, EPA

discussed the applicability of the labeling rule to methyl bromide.

With respect to containers of methyl bromide, EPA stated that such

containers would be subject to the labeling rule. With respect to

agricultural products, EPA ``determined that activities involved in

growing, harvesting, storing and transporting food are part of an

agricultural process that falls outside the intent of Congress to

require labeling on products `manufactured with' a class I or II

substance'' (58 FR at 65043, col. 3.) Based on this determination, EPA

concluded that ``products treated with methyl bromide would not require

labeling.'' Id.

In reaching its conclusion, EPA recognized that ``the general

purpose of alerting consumers that certain goods were produced in a

manner that may cause harm to stratospheric ozone could apply to

certain agricultural products for which methyl bromide is used.'' Id.

The Agency nevertheless concluded that the labeling requirement

applicable to products ``manufactured with'' a class I substance was

reasonably interpreted not to apply to agricultural products because

``such products are grown and not manufactured.'' Id. EPA cited

Webster's Ninth New Collegiate Dictionary (1983) for the ordinary

definition of the word ``manufacture'' as making something from raw

materials by hand or by machinery, which would not include the growing

of fruits and vegetables. The Agency also stated that it believed

Congress did not anticipate labeling of raw agricultural products given

the practical difficulty of labeling such products, many of which are

sold without any packaging at all.

D. Litigation

In February, 1994, the National Resources Defense Council, together

with other parties, challenged this as well as other aspects of the

methyl bromide rule by filing a petition in the U.S. Court of Appeals

for the D.C. Circuit. EPA is issuing this clarification pursuant to a

settlement agreement in that case.

II. Clarification

The need for this clarification arises out of the breadth of some

of the Agency's statements taken out of context. In isolation,

statements that ``products treated with methyl bromide'' and

``agricultural products'' do not require labeling could be interpreted

to mean that any agricultural product is exempt from the labeling rule,

regardless of whether and how methyl bromide was used in its

production. EPA's discussion of the applicability of the labeling rule

to methyl bromide addressed specific activities and types of products.

Read in context, the Agency's statements are properly limited to the

specific activities and products it addressed. The purpose of this

notice is to confirm the limits of those statements and clarify the

extent to which the labeling rule is applicable to methyl bromide.

As noted above, EPA addressed specific activities and products in

its discussion of the labeling rule's applicability to methyl bromide.

The Agency determined that ``activities involved in growing,

harvesting, storing and transporting food'' do not constitute

manufacturing under the labeling rule, and that Congress did not intend

raw agricultural products such as fruits and vegetables to be labeled.

From those determinations, EPA concluded that ``products treated with

methyl bromide would not require labeling.''

EPA's conclusion is appropriate for the specific activities and

products addressed. Growing and harvesting, as the Agency explained, do

not constitute manufacturing, since they do not fit the

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ordinary definition of manufacturing as making something from raw

materials by hand or by machinery. Indeed, agricultural crops are

generally considered ``raw materials'' that may or may not be made into

something else by hand or by machine. (See, for example, the definition

of ``raw material'' in Webster's Ninth New Collegiate Dictionary

(1990): ``wheat * * * is a raw material for the flour mill.'') As a

result, use of methyl bromide as a pesticide in growing a crop does not

make the harvested crop a product ``manufactured with'' methyl bromide.

Generally speaking, use of methyl bromide as a fumigant in storing

or transporting also does not make a product ``manufactured with''

methyl bromide. The labeling rule's definition of ``manufactured with''

specifies that the manufacturer of the product itself uses a class I

substance ``directly in the product's manufacturing.'' Storing and

transporting are generally not part of a direct manufacturing process,

although they may precede or follow such a process. By themselves,

storing and transporting also do not meet the ordinary definition of

manufacturing, since neither entails making something from raw

materials by hand or by machine. Instead, they simply provide for the

safekeeping or movement of a product, either raw or manufactured.

Further, the labeling rule requires that a product be labeled by

the time it enters interstate commerce (section 82.124.) If a product

has not been ``manufactured with'' methyl bromide by the time it enters

interstate commerce, it does not become ``manufactured with'' methyl

bromide by virtue of being treated with methyl bromide in storage or

shipment following its entry into interstate commerce. Section

82.104(n) of the rule defines the possible points of entry into

interstate commerce as the ``release of a product from the facility in

which the product was manufactured, the entry into a warehouse from

which the domestic manufacturer releases the product for sale or

distribution, and at the site of United States Customs clearance.''

Obviously, these points of entry will often precede storage or shipment

of a product in the United States.

In the methyl bromide rule preamble, EPA also discussed the

applicability of the labeling rule to particular products. The

particular products addressed by EPA--raw agricultural products,

including fruits and vegetables--result from particular activities that

EPA determined do not constitute manufacturing--growing, harvesting,

storing and transporting. It thus follows that they are not products

``manufactured with'' methyl bromide.

For the reasons given above, EPA believes that its discussion in

the methyl bromide rulemaking of the labeling rule's applicability to

methyl bromide was appropriate for the specific activities and products

addressed. However, some members of the public have raised concerns

that the discussion may be read to imply that an agricultural product

is not subject to the labeling rule even when it contains or is

manufactured with methyl bromide. The point of today's notice is to

remove any such inadvertent implication.

The labeling rule applies to any product that ``contains'' or is

``manufactured with'' a class I ozone-depleting substance. Methyl

bromide has been classified as a class I ozone-depleting substance.

Therefore, any product containing or manufactured with methyl bromide

is subject to the labeling rule's requirements in the same way as a

product containing or manufactured with any other class I substance.

For the reasons stated above, use of methyl bromide in growing,

harvesting, storing or shipping a crop does not constitute

``manufacturing with'' methyl bromide and so would not subject the crop

to the labeling requirement for products ``manufactured with'' a class

I substance. But use of methyl bromide in the direct manufacturing

process of a product would subject that product to the requirement.

EPA, however, is not aware of any agricultural product that

``contains'' or is ``manufactured with'' methyl bromide, as those terms

are defined by the labeling rule. The definition of ``product

containing'' specifies that the product ``physically holds a controlled

substance at the point of sale.'' To EPA's knowledge, no agricultural

product so holds methyl bromide, nor is it likely that any would, given

the volatility of methyl bromide. One of methyl bromide's advantages as

a pesticide and fumigant is that it leaves virtually no residues on or

in products treated with it. In any event, section 82.106(b)(1) of the

labeling rule exempts from its requirements products containing no more

than trace quantities of a controlled substance remaining as a residue

where the controlled substance serves no useful purpose in or for the

product itself. With respect to containers of methyl bromide itself,

EPA made clear in the methyl bromide rule that such containers are

subject to the labeling requirement for products ``containing'' a class

I substance.

As noted above, EPA is also not aware of any agricultural products

``manufactured with'' methyl bromide. EPA has issued several

applicability determinations related to the labeling rule. Five of them

addressed whether particular uses of a class I substance constitute

``manufacturing with'' the substance. EPA found that these particular

uses did not constitute ``manufacturing with'' a class I substance

because the class I substance did not have physical contact with the

product or was used in an intermittent, non-routine manner (which

section 82.104(o)(2) of the rule exempts from the definition of

``manufactured with.'') These applicability determinations are

available in the docket for the labeling rule.

Methyl bromide is currently used as a post-harvest pest control

tool for raisins. Grapes are typically allowed to dry in the field and

are harvested as raisins. They are then typically sold to a packer who

treats the raisins with methyl bromide when held in storage. This use

of methyl bromide would not require that the raisins be labeled.

Storage of the raisins is not manufacturing, nor is it a part of any

manufacturing process. Moreover, storage generally occurs after the

raisins have been introduced into interstate commerce.

In the case of other dried fruits and nuts, methyl bromide is used

in a similar manner. To EPA's knowledge, methyl bromide is not a direct

part of any dried fruit or nut ``manufacturing'' process, but is used

as a storage or pre-shipment pest control tool. Since these uses are

not part of a direct manufacturing process, labeling is not required.

Methyl bromide is also used to treat empty food processing

facilities for pest control. An example of such use is the periodic

fumigation of flour mills when they are empty. In these cases, food

products are typically removed from the facility prior to the methyl

bromide treatment, which takes place on an as-needed basis (typically

once or twice a year, depending on pest levels.) The methyl bromide

used in these cases has no physical contact with any food products that

are manufactured in the facility, so labeling is not required. Even if

food products were present in the facility during the methyl bromide

treatment, labeling would not be required if the treatment is done on

an intermittent or infrequent basis.

EPA may not be aware of the details of all of the processes

involving use of methyl bromide. There may be uses that are part of the

direct manufacturing process for a product and that are not otherwise

exempt from the labeling rule's definition of ``manufactured

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with.'' Any such use of methyl bromide would subject the resulting

product to the labeling rule. Similarly, any product ``containing''

methyl bromide, as that phrase is defined by the labeling rule, is

subject to the rule.

III. Submission to Congress and the General Accounting Office

The Congressional Review Act (``Act''), 5 U.S.C. section 801 et

seq., as added by the Small Business Regulatory Enforcement Fairness

Act of 1996, does not apply because this action is not a rule.

IV. Additional Information

For more information on methyl bromide, please contact the

Stratospheric Protection Hotline at 1-800-296-1996, Monday-Friday,

between the hours of 10:00 a.m. and 4:00 p.m. (EST). Federal Register

publications can be ordered from the Government Printing Office Order

Desk (202) 783-3238; the citation is the date of publication. Each of

the final rules referred to in this Notice may also be retrieved from

EPA's Ozone Depletion World Wide Web site, at http://www.epa.gov/docs/

ozone/ .

List of Subjects in 40 CFR Part 82

Environmental protection, Administrative practice and procedure,

Air pollution control, Reporting and recordkeeping requirements.

Dated: May 8, 1998.

Richard D. Wilson,

Acting Assistant Administrator for Air and Radiation.

[FR Doc. 98-12851 Filed 5-14-98; 8:45 am]

BILLING CODE 6560-50-P