9600-034 Section 4 Final Study Plan

Confidential Business Information Claims under the Toxic Substances Control Act (TSCA) (Final Rule)

2706.02 Form 9600-034_Sec 4 Final Study Plan

Rule Famiilarization

OMB: 2070-0223

Document [pdf]
Download: pdf | pdf
CBI	SUBMISSION

OMB Control No. 2070-0033 Expires 12/31/2023

SECTION	4	TEST	ORDER	-	FINAL	STUDY	PLAN

Submission	Date:

Part	I	-	Submitter	Information
Submitter
Information

Name	of	Authorized	Official

Mailing	Address

CBI

Mr	William	Brigman

123	Main	St

X

Company	Name EPA Form 9600-034

City,	State,	Zip

CDX	Test	Org

Virginia	Beach,	VA	23462

Phone	Number

Email	Address

8289191634

william.brigman@cgifederal.com
Job	Title
consultant

Part	II	-	Order	Information
Order	Number:	TO2022-1973-11650001-A

Title	of	Action:	TSCA-10973-2

Docket	Number:	EPA-HQ-OPPT-2022-1973

Part	III	-	Chemical	Information
Chemical	Substance	Name	(Regulatory	Name):	
test

Chemical	Substance
Identifier:	50-00-000
Chemical	Group:

Chemical	Category:

Part	IV	-	Test	Response	Information
OECD	416:	2-Generation	Reproduction	Toxicity
Study	Report	Deadline:	12-29-2023
File	Name

Document	Type

Attachment	Date

CBI

Attachment	for	Testing_1.docx

Study	Plan

01-05-2023

X

OECD	424:	Subchronic	Neurotoxicity	Study	in	Rodents
Study	Report	Deadline:	12-29-2023
File	Name

Document	Type

Attachment	Date

CBI

Attachment	for	Testing_1.docx

Study	Plan

01-05-2023

X
Page	1

Paperwork Reduction Act: This collection of information is approved by the United States Office of Management and Budget (OMB) under the
Paperwork Reduction Act, 44 U.S.C. 3501 et seq. (OMB Control No. 2070-0033). Responses to this collection of information are mandatory for certain
persons, as specified at 15 U.S.C. 2601 et. seq. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number. The public reporting and recordkeeping burden for this collection of information is
estimated to be 137 hours per response. Send comments on the Agency’s need for this information, the accuracy of the provided burden estimates and any
suggested methods for minimizing respondent burden to the Regulatory Support Division Director, U.S. Environmental Protection Agency (2821T), 1200
Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this
address.

CBI	SUBMISSION

Part	V	-	Technical	Contact	Information
Contact

Contact

Address

CBI

Mr	William	K	Brigman

123	Main	St

X

Company	Name

City,	State,	Zip,	Country

CDX	Test	Org

Virginia	Beach,	VA	23462,	US

Telephone	Number

Email	Address

8289191634

william.brigman@cgifederal.com

Part	VI	-	CBI	Substantiations
Claim:	Attached	Document	-	Attachment	for	Testing_1.docx	(Study	Plan)
Applicable	Only	to	General	CBI	Claims

Yes

No

CBI

A	person	may	assert	a	claim	of	confidentiality	for	the	specific	chemical	identity	of	a	chemical	substance	as	described	in	§	711.15(b)(3)	of	this	part	only	if	the	identity	of
that	chemical	substance	is	treated	as	confidential	in	the	Master	Inventory	File	as	of	the	time	the	report	is	submitted	for	that	chemical	substance.	Generic	chemical
identities	and	accession	numbers	may	not	be	claimed	as	confidential.	To	assert	a	claim	of	confidentiality	for	the	identity	of	a	reportable	chemical	substance,	you	must
submit	with	the	report	detailed	written	answers	to	the	questions	from	subsection	(b)	and	to	the	following	questions.
1. Please	specifically	explain	what	harm	to	the	competitive	position	of	your	business	would	be	likely	to	result	from	the	release	of	the	information
claimed	as	confidential.	How	would	that	harm	be	substantial?	Why	is	the	substantial	harm	to	your	competitive	position	likely	(i.e.,	probable)	to	be
caused	by	release	of	the	information	rather	than	just	possible?	If	you	claimed	multiple	types	of	information	to	be	confidential	(e.g.	site
information,	exposure	information,	environmental	release	information,	etc.),	explain	how	disclosure	of	each	type	of	information	would	be	likely	to
cause	substantial	harm	to	the	competitive	position	of	your	business.
test
2. Has	your	business	taken	precautions	to	protect	the	confidentiality	of	the	disclosed	information?	If	yes,	please	explain	and	identify	the	specific
measures,	including	but	not	limited	to	internal	controls,	that	your	business	has	taken	to	protect	the	information	claimed	as	confidential.	If	the
same	or	similar	information	was	previously	reported	to	EPA	as	non-confidential	(such	as	in	an	earlier	version	of	this	submission),	please	explain
the	circumstances	of	that	prior	submission	and	reasons	for	believing	the	information	is	nonetheless	still	confidential.
test
3A.	Is	any	of	the	information	claimed	as	confidential	required	to	be	publicly	disclosed	under	any	other	Federal	law?	If	yes,	please	explain.
test
3B.	Does	any	of	the	information	claimed	as	confidential	otherwise	appear	in	any	public	documents,	including	(but	not	limited	to)	safety	data
sheets;	advertising	or	promotional	material;	professional	or	trade	publications;	state,	local,	or	Federal	agency	files;	or	any	other	media	or
publications	available	to	the	general	public?	If	yes,	please	explain	why	the	information	should	be	treated	as	confidential.
test
3C.	Has	a	patent	been	published	for	the	chemical	identity	you	claim	confidential?	What	chemical	identity	information	is	not	revealed	by	the
patent?	How	is	release	of	that	specific	information	likely	to	cause	substantial	competitive	harm?	And	failure	to	explain	this	harm	may	lead	to
denial	of	your	confidentiality	claim.
test
4. Is	the	claim	of	confidentiality	intended	to	last	less	than	10	years	(see	TSCA	section	14(e)(1)(B))?	If	yes,	please	indicate	the	number	of	years
(between	1-10	years)	or	the	specific	date	after	which	the	claim	is	withdrawn.
test
5. Has	EPA,	another	federal	agency,	or	court	made	any	confidentiality	determination	regarding	information	associated	with	this	chemical
substance?	If	yes,	please	provide	the	circumstances	associated	with	the	prior	determination,	whether	the	information	was	found	to	be	entitled	to
confidential	treatment,	the	entity	that	made	the	decision,	and	the	date	of	the	determination.
test

X

X

X

X

X

X

X

Claim:	Technical	Contact	Information
Applicable	Only	to	General	CBI	Claims
EPA Form 9600-034

Yes

No

CBI

Page	2

CBI	SUBMISSION

A	person	may	assert	a	claim	of	confidentiality	for	the	specific	chemical	identity	of	a	chemical	substance	as	described	in	§	711.15(b)(3)	of	this	part	only	if	the	identity	of
that	chemical	substance	is	treated	as	confidential	in	the	Master	Inventory	File	as	of	the	time	the	report	is	submitted	for	that	chemical	substance.	Generic	chemical
identities	and	accession	numbers	may	not	be	claimed	as	confidential.	To	assert	a	claim	of	confidentiality	for	the	identity	of	a	reportable	chemical	substance,	you	must
submit	with	the	report	detailed	written	answers	to	the	questions	from	subsection	(b)	and	to	the	following	questions.
1.	Please	specifically	explain	what	harm	to	the	competitive	position	of	your	business	would	be	likely	to	result	from	the	release	of	the	information
claimed	as	confidential.	How	would	that	harm	be	substantial?	Why	is	the	substantial	harm	to	your	competitive	position	likely	(i.e.,	probable)	to	be
caused	by	release	of	the	information	rather	than	just	possible?	If	you	claimed	multiple	types	of	information	to	be	confidential	(e.g.	site
information,	exposure	information,	environmental	release	information,	etc.),	explain	how	disclosure	of	each	type	of	information	would	be	likely	to
cause	substantial	harm	to	the	competitive	position	of	your	business.
test
2.	Has	your	business	taken	precautions	to	protect	the	confidentiality	of	the	disclosed	information?	If	yes,	please	explain	and	identify	the	specific
measures,	including	but	not	limited	to	internal	controls,	that	your	business	has	taken	to	protect	the	information	claimed	as	confidential.	If	the
same	or	similar	information	was	previously	reported	to	EPA	as	non-confidential	(such	as	in	an	earlier	version	of	this	submission),	please	explain
the	circumstances	of	that	prior	submission	and	reasons	for	believing	the	information	is	nonetheless	still	confidential.
test
3A.	Is	any	of	the	information	claimed	as	confidential	required	to	be	publicly	disclosed	under	any	other	Federal	law?	If	yes,	please	explain.
test
3B.	Does	any	of	the	information	claimed	as	confidential	otherwise	appear	in	any	public	documents,	including	(but	not	limited	to)	safety	data
sheets;	advertising	or	promotional	material;	professional	or	trade	publications;	state,	local,	or	Federal	agency	files;	or	any	other	media	or
publications	available	to	the	general	public?	If	yes,	please	explain	why	the	information	should	be	treated	as	confidential.
test
3C.	Has	a	patent	been	published	for	the	chemical	identity	you	claim	confidential?	What	chemical	identity	information	is	not	revealed	by	the
patent?	How	is	release	of	that	specific	information	likely	to	cause	substantial	competitive	harm?	And	failure	to	explain	this	harm	may	lead	to
denial	of	your	confidentiality	claim.
test
4.	Is	the	claim	of	confidentiality	intended	to	last	less	than	10	years	(see	TSCA	section	14(e)(1)(B))?	If	yes,	please	indicate	the	number	of	years
(between	1-10	years)	or	the	specific	date	after	which	the	claim	is	withdrawn.
test
5.	Has	EPA,	another	federal	agency,	or	court	made	any	confidentiality	determination	regarding	information	associated	with	this	chemical
substance?	If	yes,	please	provide	the	circumstances	associated	with	the	prior	determination,	whether	the	information	was	found	to	be	entitled	to
confidential	treatment,	the	entity	that	made	the	decision,	and	the	date	of	the	determination.
test

X

X

X

X

X

X

X

Claim:	Submitting	Official	Information
Applicable	Only	to	General	CBI	Claims

Yes

No

CBI

A	person	may	assert	a	claim	of	confidentiality	for	the	specific	chemical	identity	of	a	chemical	substance	as	described	in	§	711.15(b)(3)	of	this	part	only	if	the	identity	of
that	chemical	substance	is	treated	as	confidential	in	the	Master	Inventory	File	as	of	the	time	the	report	is	submitted	for	that	chemical	substance.	Generic	chemical
identities	and	accession	numbers	may	not	be	claimed	as	confidential.	To	assert	a	claim	of	confidentiality	for	the	identity	of	a	reportable	chemical	substance,	you	must
submit	with	the	report	detailed	written	answers	to	the	questions	from	subsection	(b)	and	to	the	following	questions.
1.	Please	specifically	explain	what	harm	to	the	competitive	position	of	your	business	would	be	likely	to	result	from	the	release	of	the	information
claimed	as	confidential.	How	would	that	harm	be	substantial?	Why	is	the	substantial	harm	to	your	competitive	position	likely	(i.e.,	probable)	to	be
caused	by	release	of	the	information	rather	than	just	possible?	If	you	claimed	multiple	types	of	information	to	be	confidential	(e.g.	site
information,	exposure	information,	environmental	release	information,	etc.),	explain	how	disclosure	of	each	type	of	information	would	be	likely	to
cause	substantial	harm	to	the	competitive	position	of	your	business.
test
2.	Has	your	business	taken	precautions	to	protect	the	confidentiality	of	the	disclosed	information?	If	yes,	please	explain	and	identify	the	specific
measures,	including	but	not	limited	to	internal	controls,	that	your	business	has	taken	to	protect	the	information	claimed	as	confidential.	If	the
same	or	similar	information	was	previously	reported	to	EPA	as	non-confidential	(such	as	in	an	earlier	version	of	this	submission),	please	explain
the	circumstances	of	that	prior	submission	and	reasons	for	believing	the	information	is	nonetheless	still	confidential.
test
3A.	Is	any	of	the	information	claimed	as	confidential	required	to	be	publicly	disclosed	under	any	other	Federal	law?	If	yes,	please	explain.
test
3B.	Does	any	of	the	information	claimed	as	confidential	otherwise	appear	in	any	public	documents,	including	(but	not	limited	to)	safety	data
sheets;	advertising	or	promotional	material;	professional	or	trade	publications;	state,	local,	or	Federal	agency	files;	or	any	other	media	or
publications	available	to	the	general	public?	If	yes,	please	explain	why	the	information	should	be	treated	as	confidential.
test

X

X

X

X

3C.	Has	a	patent	been	published	for	the	chemical	identity	you	claim	confidential?	What	chemical	identity	information	is	not	revealed	by	the
Page	3

CBI	SUBMISSION
patent?	How	is	release	of	that	specific	information	likely	to	cause	substantial	competitive	harm?	And	failure	to	explain	this	harm	may	lead	to
denial	of	your	confidentiality	claim.
test
4.	Is	the	claim	of	confidentiality	intended	to	last	less	than	10	years	(see	TSCA	section	14(e)(1)(B))?	If	yes,	please	indicate	the	number	of	years
(between	1-10	years)	or	the	specific	date	after	which	the	claim	is	withdrawn.
test
5.	Has	EPA,	another	federal	agency,	or	court	made	any	confidentiality	determination	regarding	information	associated	with	this	chemical
substance?	If	yes,	please	provide	the	circumstances	associated	with	the	prior	determination,	whether	the	information	was	found	to	be	entitled	to
confidential	treatment,	the	entity	that	made	the	decision,	and	the	date	of	the	determination.
test

X

X

X

Part	VII	-	Certification
I	hereby	certify	to	the	best	of	my	knowledge	and	belief	that	all	information	entered	on	this	form	is	complete	and	accurate.	I	further	certify	that,	pursuant	to	15	U.S.C.	§	2613(c),	for	all
claims	for	protection	of	any	confidential	information	made	with	this	submission,	all	information	submitted	to	substantiate	such	claims	is	true	and	correct,	and	that	it	is	true	and	correct	that
I	have:
(i)	taken	reasonable	measures	to	protect	the	confidentiality	of	the	information;
(ii)	determined	that	the	information	is	not	required	to	be	disclosed	or	otherwise	made	available	to	the	public	under	any	other	Federal	law;
(iii)	a	reasonable	basis	to	conclude	that	disclosure	of	the	information	is	likely	to	cause	substantial	harm	to	the	competitive	position	of	the	person;	and
(iv)	a	reasonable	basis	to	believe	that	the	information	is	not	readily	discoverable	through	reverse	engineering.
Any	knowing	and	willful	misrepresentation	is	subject	to	criminal	penalty	pursuant	to	18	U.S.C.	§	1001.
Signature	of	authorized	official:

Date:

Page	4


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