Question attached as unit waste

williambosu

Schoolunit1...pdf

Home >Environmental science homework help >Question attached as unit waste

DOI: 10.1002/tqem.21517

W A S H I N G T O N W A T C H

Resetting the TSCA Inventory: Why This Is Important

Lynn L. Bergeson

Bergeson & Campbell, P.C. (B&C R©), Washington,

DC, USA

Correspondence

Lynn L. Bergeson, Bergeson & Campbell, P.C.

(B&C R©), Washington, DC 20037, USA

Email: [email protected]

Abstract On August 11, 2017, the U.S. Environmental Protection Agency (EPA) published the third Toxic

Substances Control Act (TSCA) framework final rule in the Federal Register, the TSCA Inven-

tory Notification (Active-Inactive) Requirements (EPA, 2017). This final rule is now in effect. This

Washington Watch column explains why the rule is important, and what stakeholders should be

doing to protect their interests.

1 B A C K G R O U N D

Under the old Toxic Substances Control Act (TSCA), the list of chem-

icals believed to be in commerce and listed on the TSCA Chemical

Inventory was widely viewed as outdated and greatly overstated the

chemicals in active commerce. While the chemicals listed on the Inven-

tory may at one point have been commercially active, it had long been

thought that many, even most, of the 85,000 or so listed chemical sub-

stances were no longer in use. Under new TSCA, Congress authorized

the Environmental Protection Agency (EPA) to “reset” the Inventory by

distinguishing between active and inactive substances. By so doing, the

EPA and the public would obtain a clear subset of chemicals in active

use in the United States and on which the EPA could better focus its

efforts to prioritize chemical substances for risk evaluation and risk

mitigation purposes.

As explained below, the final TSCA Inventory notification rule

establishes a retrospective electronic notification of chemical sub-

stances listed on the TSCA Inventory that were manufactured (includ-

ing imported) for nonexempt commercial purposes during the 10-year

time period ending on June 21, 2016, with provisions also to allow noti-

fication voluntarily by processors. The EPA will use these notifications

to distinguish active substances from inactive substances.

2 R E P O R TA B L E C H E M I C A L S U B S TA N C E S

A N D A C T I V I T I E S

The retrospective reporting requirements apply to chemical sub-

stances listed on the TSCA Inventory that were manufactured for

nonexempt commercial purposes during the 10-year period ending

on June 21, 2016. The EPA notes that this “lookback period” is set

by new TSCA (EPA, 2017, p. 37523). The forward-looking report-

ing requirements apply to substances listed as inactive on the Inven-

tory that are to be reintroduced into U.S. commerce for nonexempt

purposes.

The scope of chemical substances covered under the final rule is

reflected in the definitions of “chemical substance subject to com-

mercial activity designation” and “reportable chemical substance” that

exclude substances that are not chemical substances and substances

that are not listed on the Inventory (EPA, 2017, p. 37523). For exam-

ple, according to the EPA, a substance that is not considered a “chem-

ical substance” is not a “chemical substance subject to commercial

activity designation” or a “reportable chemical substance,” and it thus

cannot become an “active substance” or an “inactive substance” (EPA,

2017, p. 37523). A similar analysis applies with respect to a mixture,

although the EPA notes that individual Inventory-listed substances

present in the mixture may be subject to reporting. Additionally, a

substance that has not been added to the Inventory because it is

manufactured solely under a TSCA Section 5(h) exemption (e.g., low

release and low exposure exemption, low volume exemption (LVE),

polymer exemption, research and development exemption, test mar-

keting exemption) is not a “chemical substance subject to commercial

activity designation” or a “reportable chemical substance” and it cannot

become an “active substance” or an “inactive substance” (EPA, 2017,

p. 37523). Naturally occurring chemical substances are also excluded

from reporting provided that the manufacturing and processing of

such substances meet certain criteria. The EPA states that it is desig-

nating the category of “Naturally Occurring Chemical Substances” as

active substances, thereby excluding them from reporting (EPA, 2017,

p. 37523).

Manufacturing or processing a chemical substance listed on the

Inventory solely for an exempt commercial purpose is not subject to

reporting requirements. The EPA states that while it expects that many

chemical substances manufactured or processed for exempt commer-

cial purposes will not be listed on the Inventory (due to similar exemp-

tions under premanufacture notification regulations), and therefore

are already excluded from reporting, the activity exemptions listed at

40 Code of Federal Regulations (CFR) Section 710.27(a) clarify cir-

cumstances under which a person is exempt from reporting require-

ments for the manufacturing or processing of a chemical substance

122 BERGESON

that has been listed on the Inventory (e.g., due to another manufac-

turer's actions).

The final rule establishes an exemption from the retrospective

reporting requirement for three different circumstances in which the

EPA has already received equivalent notice that a chemical substance

was manufactured during the lookback period, and further require-

ment to submit a notice would therefore be inconsistent with new

TSCA Section 8(a)(5)(B):

(1) Chemical substances that are on the interim list of active sub-

stances described in new TSCA Section 8(b)(6) will be designated

as active substances, by operation of the final rule, and they

are exempted from retrospective notification requirements. The

interim list will be available on the TSCA Inventory web page

(see https://www.epa.gov/tsca-inventory) and is composed of all

chemical substances reported in 2012 or 2016 under the Chemi-

cal Data Reporting (CDR) rule (EPA, 2017, p. 37523);

(2) Chemical substances added to the Inventory during the 10-year

time period ending on June 21, 2016, pursuant to a Notice of Com-

mencement (NOC) under 40 CFR Section 720.102 received by

EPA between June 21, 2006, and June 21, 2016, will be designated

as active substances, by operation of the final rule, and they are

exempted from retrospective notification requirements under the

rule. An NOC is required to be submitted on or no later than 30 cal-

endar days after the first day of manufacture for commercial pur-

pose. Additionally, an NOC substance is considered to be added to

the Inventory on the date the NOC is received by EPA, provided

that EPA determines the NOC to be valid during its review (EPA,

2017, p. 37523); and

(3) A manufacturer is exempted from the retrospective notification

requirements under the rule, for a particular chemical substance,

if the manufacturer has evidence in the form of a Central Data

Exchange (CDX) receipt, documenting EPA's receipt of a Notice of

Activity (NOA) Form A from another manufacturer; see 40 CFR

Section 710.25(a). EPA notes that manufacturers “bear the risk

of failing to submit a required forward-looking notification (NOA

Form B) notice if they rely on this Form A exemption, and the Form

A notice (for which they have a CDX receipt) is later withdrawn,

leading to the substance being designated as inactive” (EPA, 2017,

p. 37524).

The EPA states that persons who manufactured or processed a

chemical substance listed on the confidential portion of the Inventory,

which was added to the Inventory prior to June 22, 2016, should rec-

ognize that they must submit an NOA Form A if they wish to indicate

that they “seek to maintain an existing claim for protection against dis-

closure of the specific chemical identity of the substance as confiden-

tial” (EPA, 2017, p. 37524). This includes persons that, during the look-

back period, manufactured or processed a confidential substance on

the Inventory for which the EPA already has an equivalent notice. It

may also potentially include persons that, during the lookback period,

manufactured or processed a confidential substance on the Inventory

for an exempt commercial purpose, if such substance is designated

active due, for instance, to the EPA's receipt of an equivalent notice

(such as an NOC or CDR report). In connection with extending manu-

facturers’ reporting exemptions to cover substances on the confiden-

tial portion of the Inventory, the EPA states that it revised 40 CFR

Section 710.25(b) to clarify manufacturers’ and processors’ discretion

to report. If manufacturers elect not to submit a notice because they

are availing themselves of one of the exemptions described above,

“then they are foregoing their opportunity to maintain an existing claim

for protection against disclosure of the specific chemical identity of the

substance as confidential” (EPA, 2017, p. 37524). The EPA notes that

it is required, by statute, to move from the confidential to the public

portion of the Inventory any active chemical substance for which no

request is received to maintain an existing confidential business infor-

mation (CBI) claim for chemical identity.

In connection with extending manufacturers’ reporting exemptions to cover substances on the confidential portion of the Inventory, the EPA states that it revised 40 CFR Section 710.25(b) to clarify manufacturers’ and processors’ discretion to report.

Chemical substances added to the Inventory on or after June 22,

2016, will be designated as active, and such substances are not subject

to reporting under the rule. Furthermore, according to the EPA, such

substances are beyond the scope of the CBI claim maintenance provi-

sion under new TSCA Section 8(b)(4)(B)(ii). This CBI maintenance pro-

vision is intended to address “existing claim[s] for protection against

disclosure of the specific chemical identity.” The EPA states that it

interprets this “to be a reference to CBI claims asserted prior to June

22, 2016” (EPA, 2017, p. 37523).

3 T I M I N G O F R E P O R T I N G

Pursuant to the rulemaking, the retrospective reporting period for

manufacturers begins on August 11, 2017, and ends on February 7,

2018. The submission period for processors also begins on August

11, 2017, but processors have until October 5, 2018, to submit ret-

rospective activity notifications. According to the EPA, the 180-day

time period for this retrospective reporting for manufacturers is the

https://www.epa.gov/tsca-inventory

BERGESON 123

maximum time allowed under new TSCA Section 8(b)(4)(A). Follow-

ing this retrospective reporting for manufacturers, the EPA will include

the active designations, determined by the notices received, on a draft

of the Inventory. The EPA will publish the draft Inventory with the

active designations “as soon as is practicable” following the close of the

180-day submission period. The draft Inventory will not have the legal

effect of actually designating any chemical substance as inactive, how-

ever, and the EPA does not construe it as the list with “designations of

active substances and inactive substances” (EPA, 2017, p. 37524) from

which forward-looking reporting commences. The EPA states that it

concludes that new TSCA is referring to the completed product of the

initial cycle of sorting between active and inactive substances, not the

preliminary product of the initial cycle of such sorting.

Processors may report to the EPA not later than 420 days after the

final rule is published in the Federal Register, or by October 5, 2018.

Processors have the option “to simply not report under TSCA section

8(b)(4) and continue processing until the effective date of EPA's des-

ignation of a chemical substance as inactive on the Inventory” (EPA,

2017, p. 37524). At such time, any further processing of the substance

for a nonexempt commercial purpose, without prior notification to the

EPA, will be prohibited by new TSCA Section 8(b)(5). The EPA notes

that earlier notification under new TSCA Section 8(b)(4) will allow the

EPA to add the substance to the Inventory as an active substance, so

that processing can continue without the need for a later notification.

The EPA notes that earlier notification under new TSCA Section 8(b)(4) will allow the EPA to add the substance to the Inventory as an active substance, so that processing can continue without the need for a later notification.

The forward-looking reporting period begins on the effective date

of the EPA's final active/inactive substance designations. Manufactur-

ers and processors intending to reintroduce into U.S. commerce for a

nonexempt commercial purpose a chemical substance designated as

inactive on the Inventory must report to the EPA not more than 90 days

before the anticipated date of manufacturing or processing.

The EPA states that the structure of the reporting requirements

under new TSCA Sections 8(b)(4)(A) and 8(b)(5)(B) results in a tran-

sitional period beginning on June 22, 2016, (the day after the look-

back period for retrospective reporting ends), and ending on the date

that the EPA designates chemical substances on the Inventory as

active or inactive (the day that forward-looking reporting begins). It

is possible that substances that were not manufactured or processed

during the lookback period—and therefore cannot be designated as

active through retrospective reporting—may be reintroduced into U.S.

commerce during this transitional period. In response to comments,

the EPA is establishing an effective date provision for the designa-

tion of a chemical substance as an inactive substance. As “inactive sub-

stance” is now defined, a substance is not considered to be “inactive”

until 90 days after the EPA has designated the substance as inactive.

The EPA states that it will identify chemical substances for inactive

designation in a signed action accompanying the first version of the

Inventory with all final active–inactive listings.

Accordingly, the final rule clarifies that the obligation to submit an

NOA Form B does not arise until 90 days after the EPA has identified

chemical substances for the inactive designation. The rule also clarifies

that manufacturers and processors will be permitted to submit an NOA

Form B for a substance that the EPA has identified for inactive designa-

tion before the effective date of such designation, and thus, before the

substance has the legal status of being inactive.

4 I N F O R M AT I O N T O B E R E P O R T E D

Manufacturers reporting for the retrospective reporting period must

provide chemical identity information and indicate whether they seek

to maintain an existing claim for protection against disclosure of a CBI

chemical identity, if applicable. The EPA did not issue in final the pro-

posed requirements to report commercial activity type and date range.

The final rule clarifies that persons required to report will provide

information to the extent it is known to or reasonably ascertainable

by them. The EPA states that it is not establishing a formal corrections

provision in the regulation, but it will allow a manufacturer or proces-

sor to withdraw an NOA Form A, provided that the withdrawn notice

is submitted prior to the end of the submission period for processors

(i.e., not later than 420 days after the final rule is published in the Fed-

eral Register). The manufacturer may effect a correction by filing a new

NOA Form A following withdrawal, so long as the new Form A is filed

within the time provided in the rule for the initial filing (i.e., no later

than 180 days after the final rule is published in the Federal Register).

The EPA states that processors that choose to report for the ret-

rospective reporting period will be required to provide chemical iden-

tity information and whether they seek to maintain an existing claim

for protection against disclosure of a CBI chemical identity, if applica-

ble. The EPA removed the proposed requirements to report commer-

cial activity type and date range, as these requirements were deemed

unnecessary to achieve the objective of designating substances as

active or inactive on the Inventory. The EPA states that it is not estab-

lishing a formal corrections provision in the regulation for an NOA

Form A, but it will allow a processer to withdraw an NOA Form A, pro-

vided that the withdrawn notice is submitted not later than 420 days

after the final rule is published in the Federal Register. As with manu-

facturers, the EPA notes that processors can effectuate a correction by

filing a new Form A within the time provided in the rule for the initial

filing (i.e., no later than 420 days after the final rule is published in the

Federal Register).

124 BERGESON

The final rule requires that persons that intend to manufacture or

process an inactive substance for nonexempt commercial purpose pro-

vide chemical identity information, the anticipated date of manufac-

turing or processing for nonexempt commercial purpose, and whether

they seek to maintain an existing claim for protection against disclo-

sure of a CBI chemical identity, if applicable.

The EPA received requests that submitters be able to withdraw an

NOA Form B if their intent to recommence manufacture or processing

of a chemical substance later changes. In response, the EPA will allow a

submitter to request to withdraw its NOA Form B, and the EPA may do

so, if the EPA has not yet altered the Inventory status of the substance

in response to the original submission (i.e., the EPA has neither redes-

ignated the substance from inactive to active nor moved the substance

from the confidential portion of the Inventory to the public portion of

the Inventory as a result of a request in the original submission for a

CBI claim to be withdrawn). The EPA notes that because another per-

son may have commenced manufacturing or processing for nonexempt

commercial purpose in reliance on a substance being redesignated as

active, the rule does not allow for the EPA to revert a substance redes-

ignated as active back to inactive status based on a request to with-

draw an NOA Form B, or for the EPA to revert a non-CBI substance

back to a CBI substance based on a request to withdraw a Form B.

The NOA Form A will be used by manufacturers for the retrospec-

tive reporting period. It will also be used by processors who choose to

report for the retrospective reporting period. The NOA Form B will be

used by manufacturers and processors for forward-looking reporting,

which includes reporting chemical substances reintroduced into U.S.

commerce during the transitional period.

The NOA Form B will be used by manufacturers and processors for forward-looking reporting, which includes reporting chemical substances reintroduced into U.S. commerce during the transitional period.

5 S U B M I S S I O N O F I N F O R M AT I O N T O E PA

The final rule requires electronic reporting similar to the requirements

established in 2013 for submitting other information under TSCA. Sub-

mitters will use the EPA's CDX and the EPA's Chemical Information

Submission System, a web-based reporting tool, for all reporting under

the rule. The EPA states that it expects that electronic reporting will

minimize time requirements, support improved data quality, and pro-

vide efficiencies for both submitters and the EPA.

6 C B I C L A I M S A N D R E Q U E S T S

Notices pursuant to the rule may contain two different types of CBI

assertions: claims for protection of information other than specific

chemical identity and requests to maintain existing claims for protec-

tion of specific chemical identity. The EPA states that it extensively

rewrote the substantiation questions from the proposed rule in a man-

ner intended to secure more succinctly responses for CBI assertions of

discrete data elements, as well as CBI concerns on the linkage of data

elements.

For all new claims for protection (i.e., for all CBI assertions other

than requests to maintain existing claims for protection of specific

chemical identity), new TSCA Section 14(c)(1)(B) and 14(c)(5) requires

that persons claiming CBI must provide a specific certification state-

ment regarding the basis for the CBI claims. In addition, new TSCA

Section 14(c)(3) and this rule require that all such claims be substan-

tiated at the time of submission. The EPA will review a representative

subset of these claims as specified by new TSCA Section 14(g)(1).

Any manufacturer or processor submitting an NOA under new

TSCA Section 8(b)(4)(A) may seek to maintain an existing CBI claim for

specific chemical identity, regardless of whether that person asserted

the original claim that caused the specific chemical identity to be

listed on the confidential portion of the Inventory. The EPA states

that it believes this is the correct interpretation of “a manufacturer

or processor … that seeks to maintain an existing claim for protec- tion against disclosure” of specific chemical identity in new TSCA Sec-

tion 8(b)(4)(B)(ii). According to the EPA, “[a] number of manufacturers

and processors may legitimately benefit from the confidential status

of a specific chemical identity, even when such persons did not origi-

nally report that chemical identity to EPA and therefore were not in a

position to assert a CBI claim for that chemical identity” (EPA, 2017,

p. 37527). The EPA does not believe that Congress intended for spe-

cific confidential chemical identities to be disclosed without providing

the opportunity for manufacturers and processors to make a request

that the identities should remain confidential simply because the orig-

inal claimants did not file under new TSCA Section 8(b)(4)(B)(ii).

Pursuant to new TSCA Section 8(b)(4)(B)(iv), the EPA will move an

active substance from the confidential portion of the Inventory to the

nonconfidential portion if no manufacturer or processor submitting

an NOA under new TSCA Section 8(b)(4)(A) requests to maintain the

existing CBI claim for the specific chemical identity of that chemical

substance. The EPA states that, as a courtesy, its practice is to notify

original claimants and/or the public when it has moved substances

from the confidential portion of the Inventory to the public portion of

the Inventory, (e.g., through direct contact with the original claimant or

publication of a Federal Register notice). A chemical substance for which

the EPA has received a request to maintain an existing CBI claim for

specific chemical identity will remain on the confidential portion of the

BERGESON 125

Inventory pending the EPA's review of the claim pursuant to a review

plan to be promulgated at a later date.

A chemical substance for which the EPA has received a request to maintain an existing CBI claim for specific chemical identity will remain on the confidential portion of the Inventory pending the EPA's review of the claim pursuant to a review plan to be promulgated at a later date.

While the final rule requires submitters to indicate whether they

seek to maintain an existing CBI claim for specific chemical identity, the

rule does not include mandatory substantiation requirements for CBI

requests for specific chemical identity on an NOA Form A. New TSCA

Section 8(b)(4)(B)(iii) stipulates that the EPA shall “require the substan-

tiation of those claims pursuant to section 14 and in accordance with

the review plan described in subparagraph C” (EPA, 2017, p. 37527).

The EPA states that it will conduct a separate rulemaking to estab-

lish this review plan. The review plan will include mandatory require-

ments for substantiating a CBI request for specific chemical identity

reported in an NOA Form A and specify when such substantiation is to

be provided. If the EPA receives an NOA Form A in which the submitter

requests to maintain an existing CBI claim for specific chemical identity

but chooses not to substantiate such at the time of filing, the EPA will

continue to list the chemical substance on the confidential portion of

the Inventory pending the submission of any substantiation required

under the review plan and the EPA's review of the claim pursuant to

the review plan.

The EPA notes that under the rule, it is allowing companies to sub-

mit substantiation for the CBI claims for specific chemical identity at

the same time that the NOA Form A is filed, however, if they so choose.

Provided the period between the date these earlier substantiations are

received and the due date to be established in the review plan (yet

to be proposed) is not more than five years, these substantiations will

exempt the company from the requirement to submit additional sub-

stantiation under the terms of the review plan.

With respect to requests to maintain existing CBI claims that are

submitted on an NOA Form B, new TSCA Section 8(b)(5)(B) stipu-

lates that such requests must be substantiated not later than 30 days

after submitting Form B. Substantiation requirements for NOA Form

B CBI claims for specific chemical identity are found in 40 CFR Section

710.37(a)(2). The EPA states that it will allow companies to submit sub-

stantiation at the same time that their NOA Form B is filed, if they so

choose.

7 D I S C U S S I O N

The final rule is thoughtful and well crafted. The EPA's decision to

withdraw its proposal to include the activity type and dates of activ-

ity was the right one, recognizing that the required recordkeeping pro-

vides the EPA the necessary documentation of the reported commer-

cial activity. The proposal to require dates of activity was especially

problematic because records older than five years may not be rou-

tinely available and the nature of some manufacturing, processing, and

importing practices are highly variable, making it difficult for reporters

to specify a date range.

Importantly, the EPA clarified which substances must be reported.

The EPA recognized that any substance for which an NOC was filed

in the lookback period satisfies the requirement to demonstrate com-

mercial activity, and the EPA will add such substances to the list of

interim active substances that already included substances reported

under the 2012 or 2016 CDR cycles. The EPA disagreed with com-

menters who argued that polymers listed on the Inventory should

be designated as active substances. The EPA stated that new TSCA

required reporting on all substances manufactured during the look-

back period; there is no exemption for low-hazard substances or sub-

stances that might be eligible for an exemption.

The EPA further clarified that substances that are not listed on the

Inventory but are manufactured under an exemption are exempt from

NOA reporting. In the case that a company currently manufactures

a substance under an exemption (e.g., an LVE), if the substance is

listed on the public portion of the Inventory, the company is required

to submit an NOA. On the other hand, if a company manufactures a

substance under an LVE that may be listed on the confidential portion

of the Inventory, the company need not determine the Inventory

status through a bona fide intent notice and the company is exempt

from NOA reporting. In summary, if a substance is manufactured under

an exemption (e.g., LVE or polymer exemption) and the substance is not

known to the manufacturer to be listed on the Inventory, an NOA is not

required.

A critical problem that the EPA addresses in the final rule relates

to the transition period between June 22, 2016, and when the list of

active substances is published. The proposed rule required an NOA for

activity in the lookback period (prior to June 22, 2016) and NOA sub-

mission for inactive substances after the publication of the list of active

substances. There was no provision for an NOA for commercial activity

that occurred between June 22, 2016, and the publication of the list of

active substances. That is, a manufacturer that commenced importing

an existing chemical substance in January 2017 had no mechanism to

report such activity to the EPA and, if no other company reported the

substance as active, could find itself importing an inactive substance

when the final list is published. To prevent this situation, the EPA has

implemented a 90-day period after the final list is published in which

126 BERGESON

manufacturers can submit a prospective (Form B) NOA for a substance

that appears as inactive on that list.

The EPA responded to concerns about the meaning of “known or

reasonably ascertainable,” especially as the term relates to company

mergers, acquisitions, and divestitures. The EPA provided additional

guidance and refers to the guidance published to support the 2016

CDR reporting cycle. In particular, the EPA rejected the argument that

information that is not “readily obtainable” meets the definition of not

known or reasonably ascertainable.

Publication of the rule is just the first step in resetting the Inventory.

Now the hard work begins, and submitters need to prepare their sub-

mission, and the EPA will need to prepare to process these submissions.

Although it will take a lot of effort, a reset Inventory is an important

product of the new TSCA and well worth the effort. For the first time

in a long time, we will have a chemical Inventory that more accurately

reflects chemicals in commerce.

R E F E R E N C E

Environmental Protection Agency. (2017). TSCA Inventory Notification

(Active–Inactive) Requirements. Friday, August 11, 2017/Rules and

Regulations/ Federal Register, 82(154), 37520–37544. Retrieved from https://www.gpo.gov/fdsys/pkg/FR-2017-08-11/pdf/2017-15736.pdf

A U T H O R'S B I O G R A P H Y

Lynn L. Bergeson is Managing Partner of Bergeson & Campbell,

nanoscale, and biobased industrial, agricultural, and specialty chem-

ical product regulation and approval matters, environmental health

and safety law, chemical product litigation, and associated business

counseling and litigation issues. Lynn is President of The Acta Group

with offices in Washington, DC.

How to cite this article: Bergeson LL. Resetting the TSCA

Inventory: Why This Is Important. Environmental Quality

Management. 2017;27:121–126. https://doi.org/10.1002/tqem

.21517

https://www.gpo.gov/fdsys/pkg/FR-2017-08-11/pdf/2017-15736.pdf

https://doi.org/10.1002/tqem.21517

Copyright of Environmental Quality Management is the property of John Wiley & Sons, Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.